protocol_id stringclasses 263
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NCT05452798 | 2 | LIST OF ABBREVIATIONS | 2. LIST OF ABBREVIATIONS | Abbreviation | Definition | | | |--------------|---------------------------------------------------------------------------|--|--| | AI | Aromatase inhibitor | | | | a/MBC | Advanced metastaticbreast cancer | | | | CDK | Cyclin-dependent kinase | | | | CDK4 | Cyclin Dependent Kinase 4 | | | |... | [] |
NCT05452798 | 3 | RESPONSIBLE PARTIES | 3. RESPONSIBLE PARTIES
Principal Investigator(s) of the Protocol | Name, degree(s) | Job Title | Affiliation | Address | | |-----------------|-----------|-------------|---------|--| | PPD | PPD | PPD | PPD | | | MD, MSc | | | PPD | | | PPD, | PPD | PPD | PPD | | | MSc, PhD | | | PPD | | | | | | PPD | | | PPD | | PPD |... | [
"Principal Investigator(s) of the Protocol"
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NCT05452798 | 4 | ABSTRACT | 4. ABSTRACT
Title A Retrospective Non-interventional Study of Breast Cancer Patients Diagnosed With HR+/HER2- Locally Advanced or Metastatic Breast Cancer Treated With Palbociclib in Denmark.
Authors 
Rationale and background There is a need for additional and updated real-world evidence (RWE) ... | [
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NCT05452798 | 5 | AMENDMENTS AND UPDATES | 5. AMENDMENTS AND UPDATES None. | [] |
NCT05452798 | 6 | MILESTONES | 6. MILESTONES | Milestone | Planned date | |--------------------------------------------------------------------|------------------------------| | Final Protocol | 17 December 2021 | | Final Statistical Analysis Plan | 31 January 2022 | | Start of data collection (FSFV – database study,historic data) | 01 February 2022... | [] |
NCT05452798 | 7 | RATIONALE AND BACKGROUND | 7. RATIONALE AND BACKGROUND The discovery and development of CDK4/CDK6 inhibitors have revolutionized the paradigm of therapeutic management of HR+ MBC worldwide. The most common cancer globally is breast cancer (1). In Denmark, breast cancer is the most frequent cancer in women, with approximately 4,700 new cases per ... | [] |
NCT05452798 | 8 | RESEARCH QUESTION AND OBJECTIVES | 8. RESEARCH QUESTION AND OBJECTIVES In general, the overall objective is using data from the Danish DBCG registry to retrospectively describe and assess clinical and demographical characteristics, treatment patterns in a RW setting of patients with HR+/HER2- locally advanced or metastatic breast cancer receiving palboc... | [
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NCT05452798 | 8.1 | Definitions | 8.1. Definitions PFS is defined as the date of relapse or stage IV disease (index date) to progression or death, whichever occurs first. - Patients will be censored for PFS by 31 December 2020 - Progression of disease is based on scans and blood testing results ToT is defined as date of palbociclib treatment start to d... | [] |
NCT05452798 | 9 | RESEARCH METHODS | 9. RESEARCH METHODS | [] |
NCT05452798 | 9.1 | Study design | 9.1. Study design The study is designed as a secondary data collection NIS based on retrospective data from an existing registry focusing on HR+/HER2- locally advanced or metastatic breast cancer treated with palbociclib. The study is a single-arm study only focusing on patients treated with palbociclib in Denmark. The... | [] |
NCT05452798 | 9.2 | Setting | 9.2. Setting In the DBCG registry, patients with HR+/HER2- locally advanced or metastatic breast cancer treated with palbociclib will be identified. Palbociclib was approved by the European Commission (EC) and European Medicines Agency (EMA) in November 2016. Hence, the study period will be 2017-2020. A follow-up on pa... | [] |
NCT05452798 | 9.2.1 | Inclusion criteria | 9.2.1. Inclusion criteria Patients must meet the following inclusion criteria to be eligible for inclusion in the study : - 1. Patients with breast cancer (ICD-10: DC50) - 2. A diagnosis of HR+/HER2- locally advanced or metastatic breast cancer - 3. Initiated treatment with palbociclib as either 1st or 2nd line treatme... | [] |
NCT05452798 | 9.2.2 | Exclusion criteria | 9.2.2. Exclusion criteria There are no exclusion criteria for this study. | [] |
NCT05452798 | 9.3 | Variables | 9.3. Variables The main variables included in the study are the following:
Table 1. List of variables | Variable | Role | Data source(s) | DBCG variable(s) | |---------------------------------------------------------------------------------------------------------------------|-------------------------|----------------... | [
"Table 1. List of variables"
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NCT05452798 | 9.4 | Data sources | 9.4. Data sources This study will be based solely on the DBCG registry. No other Danish healthcare registries will be included. The DBCG registry also includes information on death. | [] |
NCT05452798 | 9.5 | Study size | 9.5. Study size It is estimated that the total population of palbociclib-treated patients with HR+/HER2 locally advanced or metastatic breast cancer included in the DBCG registry constitutes of 1,500 patients since the introduction of palbociclib in Denmark (from 01 January 2017 to 31 December 2020). | [] |
NCT05452798 | 9.5.1 | Sub-groups | 9.5.1. Sub-groups In addition, the primary objective (PFS, ToT) as well as some of the secondary objectives (OS and first subsequent post-palbociclib treatment) will be addressed for the following subgroups such as those below provided sample size is sufficient: - Specific age groups (below 50 years, 50 -70, and above ... | [] |
NCT05452798 | 9.6 | Data management | 9.6. Data management The Danish Breast Cancer Group hosts the DBCG registry and all analyses will be performed by DBCG's biostatistical researchers following this protocol and a pre-specified SAP. Pfizer will not have access to data at the individual level – only summary data in tables produced by DBCG as part of the d... | [] |
NCT05452798 | 9.7 | Data analysis | 9.7. Data analysis In general, some research questions will be addressed via descriptive statistics, including stratification on sub-groups. In the PFS and OS analyses, Kaplan-Meier survival distribution functions will be estimated, implying that statistics on median survival expectedly will be available. Overall survi... | [] |
NCT05452798 | 9.8 | Quality control | 9.8. Quality control DBCG's biostatistical researchers will compile the full data set and perform the analyses. The researchers will follow generally accepted methods as well as DBCG's internal guidelines for data analysis. The study involves analyses of individual data. DBCG's biostatistical researchers will, however,... | [] |
NCT05452798 | 9.9 | Strengths and limitations of the research methods | 9.9. Strengths and limitations of the research methods Naturally, this study has both strengths and limitations. DBCG has provided a long history of compiling and maintaining registry data since the past 40 years. The data from DBCG has been part of both national and international studies. In addition the data collecte... | [] |
NCT05452798 | 9.10 | Other aspects | 9.10. Other aspects Not applicable. | [] |
NCT05452798 | 10 | PROTECTION OF HUMAN SUBJECTS | 10. PROTECTION OF HUMAN SUBJECTS All parties will ensure protection of patient personal data and will not include patient names on any sponsor forms, reports, or publications, or in any other disclosures except where required by law. As described, DBCG's biostatistical researchers will have access only to data in de-pe... | [] |
NCT05452798 | 10.1 | Patient information | 10.1. Patient information This study involves data that exist in anonymized structured format and contain no patient personal information. | [] |
NCT05452798 | 10.2 | Patient consent | 10.2. Patient consent As this study involves anonymized structured data, which according to applicable legal requirements do not contain data subject to privacy laws, obtaining informed consent from patients by Pfizer is not required. | [] |
NCT05452798 | 10.3 | Institutional review board (IRB)/Independent ethics committee (IEC) | 10.3. Institutional review board (IRB)/Independent ethics committee (IEC) Approval from the Danish Data Protection Agency is not necessary for this type of study. However, in accordance with General Data Protection Regulation (GDPR) the study will be reported via Pactius to the Capital Region of Denmark's research list... | [] |
NCT05452798 | 10.4 | Ethical conduct of the study | 10.4. Ethical conduct of the study The study will be conducted in accordance with legal and regulatory requirements, as well as with scientific purpose, value, and rigor, and will follow generally accepted research practices described Good practices for real-world data studies of treatment and/or comparative effectiven... | [] |
NCT05452798 | 11 | MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE REACTIONS | 11. MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE REACTIONS This study involves data that exist as structured data by the time of study start or a combination of existing structured data and unstructured data, which will be converted to structured form during the implementation of the protocol solely by a computer... | [] |
NCT05452798 | 12 | PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS | 12. PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS Besides a study report presenting the results, a manuscript for a scientific article will be written and submitted to an international peer-reviewed journal. Authorship of the article manuscripts will follow the requirements set by the International Committee ... | [] |
NCT05452798 | 13 | REFERENCES | 13. REFERENCES - 1. Bray F, Ferlay J, Soerjomataram I, et al. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 2018;68(6):394-424. - 2. https://medicinraadet.dk/media/oyvbnp31/medicinr%C3%A5dets-protokol-for-abemaciclib-tilfremskred... | [] |
NCT05452798 | 14 | LIST OF TABLES | 14. LIST OF TABLES Table 1. List of variables (see section 9.3). | [] |
NCT05452798 | 15 | LIST OF FIGURES | 15. LIST OF FIGURES Not applicable.
ANNEX 1. LIST OF STAND ALONE DOCUMENTS Not applicable.
ANNEX 2. ADDITIONAL INFORMATION Not applicable. | [
"ANNEX 1. LIST OF STAND ALONE DOCUMENTS",
"ANNEX 2. ADDITIONAL INFORMATION"
] |
NCT05576012 | 1 | SIGNATURE PAGE FOR LIPUM AB | 1 SIGNATURE PAGE FOR LIPUM AB Hereinafter called Lipum AB Investigational drug name: SOL-116 Protocol number: LPM-116-001  
2 Investigational drug name: SOL-116 Protocol number: LPM-116-001 I agree to the terms and conditions relating to this study as defined in this protoc... | [
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NCT05576012 | 4 | LIST OF ABBREVIATIONS | 4 LIST OF ABBREVIATIONS ACR American College of Rheumatology ADA Anti-drug antibodies AE Adverse event ALP Alkaline phosphatase ALT Alanine aminotransferase aPTT Activated partial thromboplastin time AST Aspartate aminotransferase ATC Anatomic Therapeutic Chemical AUC Area under the concentration-time curve AUC0-inf AU... | [] |
NCT05576012 | 5 | PROTOCOL SYNOPSIS | 5 PROTOCOL SYNOPSIS | TITLE | A Randomized, Double-Blind, Placebo-Controlled, Firstin-Human Phase I Study Evaluating Safety, Tolerabilityand Pharmacokinetics of Single Ascending Doses ofSOL-116 (a Humanized Monoclonal Anti-BSSL Antibody)in Healthy Subjects and Patients with Rheumatoid Arthritis | |---------------------... | [
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NCT05576012 | 05 | August Clinical 2024, Study Amendment Protocol | 05 August Clinical 2024, Study Amendment Protocol  | QPScode:Sponsorcode: | 210463-CS0382LPM-116-001 | | | | Clinical05 August | Study2024, | ProtocolAmendment | 6 | | | | eQPS" | T | |---------------------------------------------------------------------------------------------------------------... | [
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NCT05576012 | 6 | INTRODUCTION AND RATIONALE | 6 INTRODUCTION AND RATIONALE | [] |
NCT05576012 | 6.1 | Background | 6.1 Background Rheumatoid arthritis (RA) is a chronic autoimmune inflammatory joint disease characterized by varying numbers of swollen, stiff and painful joints typically in hands and feet, but any joint may be affected. With time, erosion of joints and bone results in varying degree of disability and loss of quality ... | [] |
NCT05576012 | 6.1.1 | Product Characteristics The intended product SOL-116 is a humanized monoclonal anti-Bile Salt-Stimulated Lipase (BSSL) antibody of the IgG4 S228P subclass The therapeutic approach for the antibody SOL-116 is to block the function of BSSL in chronic inflammatory conditions with a lead indication to prevent inflammation ... | 6.1.1 Product Characteristics The intended product SOL-116 is a humanized monoclonal anti-Bile Salt-Stimulated Lipase (BSSL) antibody of the IgG4 S228P subclass The therapeutic approach for the antibody SOL-116 is to block the function of BSSL in chronic inflammatory conditions with a lead indication to prevent inflamm... | [] |
NCT05576012 | 6.1.3 | Clinical Experience with SOL-116 (current study) | 6.1.3 Clinical Experience with SOL-116 (current study) To date, Part 1 has been concluded. Five cohorts with 8 healthy subjects (male and female) per cohort have been administered SOL-116 or placebo (6 active and 2 placebo), up to 6.075 mg/kg single dose. There were 25 males and 15 females enrolled, age range 22 to 64 ... | [] |
NCT05576012 | 6.2 | Study Rationale | 6.2 Study Rationale SOL-116 is a new monoclonal antibody targeting BSSL that is developed for the treatment of RA. There are preliminary data showing increased concentration of serum BSSL in patients with inflammatory conditions compared to healthy individuals [7]. The aim of the study is to achieve safety, tolerabilit... | [] |
NCT05576012 | 6.2.1 | Rationale for Study Design | 6.2.1 Rationale for Study Design The design of the SAD study is based on the aim to study safety, tolerability and pharmacokinetics (PK) of selected doses of SOL-116 in a limited number of healthy subjects and in a cohort of RA patients. Fertile women are allowed to enter the study. SOL-116 has not been investigated wi... | [] |
NCT05576012 | 6.3 | Dose Selection | 6.3 Dose Selection | 6.3.1 | Selection of Starting Dose in Part 1 SAD | |-------|------------------------------------------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |... | [] |
NCT05576012 | 7 | STUDY OBJECTIVES | 7 STUDY OBJECTIVES | [] |
NCT05576012 | 7.1 | Study Objectives for Single Dosing (Parts 1 and 2) | 7.1 Study Objectives for Single Dosing (Parts 1 and 2)
Primary objective: • To evaluate the safety and tolerability of single ascending doses of SOL-116 in healthy subjects and RA patients.
Secondary objective: - To determine single dose PK characteristics of SOL-116 in healthy subjects and RA patients. - To assess t... | [
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NCT05576012 | 7.2 | Study Objectives for Multiple Dosing (Part 3) | 7.2 Study Objectives for Multiple Dosing (Part 3)
Primary objective: • To evaluate the safety and tolerability of multiple dosing of SOL-116 in healthy subjects.
Secondary objective: - To determine multiple dose PK characteristics of SOL-116 in healthy subjects. - To assess the immunogenicity of SOL-116 after multipl... | [
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NCT05576012 | 8 | STUDY DESIGN | 8 STUDY DESIGN | [] |
NCT05576012 | 8.1 | Endpoints | 8.1 Endpoints | [] |
NCT05576012 | 8.1.1 | Primary Endpoints (all parts) | 8.1.1 Primary Endpoints (all parts) • Adverse events (type, frequency, severity, and relationship of adverse events (AEs) to study drug treatment), clinical laboratory evaluations (including blood haematology/plasma biochemistry analyses and urinalyses), immune reactions, vital signs, electrocardiogram (ECG) and inject... | [] |
NCT05576012 | 8.1.2 | Secondary Endpoints | 8.1.2 Secondary Endpoints | [] |
NCT05576012 | 8.1.2.1 | Secondary Endpoints | 8.1.2.1 Secondary Endpoints - PK of SOL-116 variables for single dose regimens: area under the serum concentration-time from time zero to infinity (AUC0-inf), AUC from time zero to time t of the last measured concentration above the limit of quantification (AUC0-t), area under the serum concentration-time from time zer... | [] |
NCT05576012 | 8.1.2.2 | Secondary Endpoints Part 3 only | 8.1.2.2 Secondary Endpoints Part 3 only PK of SOL-116 variables for the last dose: area under the serum concentration-time from time zero to the end of dosing interval (AUC0-tau), maximum observed serum concentration (Cmax), time to Cmax (Tmax), minimum observed serum concentration (Ctrough), average serum concentratio... | [] |
NCT05576012 | 8.1.3 | Exploratory Endpoints (all parts) | 8.1.3 Exploratory Endpoints (all parts) - Change from baseline in BSSL concentration in blood. - Change from baseline in inflammatory biomarkers, i.e.serum C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) for all subjects/patients and S-calprotectin and high sensitive CRP (hsCRP) (only RA patients). - Cha... | [] |
NCT05576012 | 8.2 | Overall Study Design | 8.2 Overall Study Design This is a randomized, double-blind, placebo-controlled phase I, first-in-human (FIH) study designed to evaluate the safety, tolerability and PK of single SC ascending doses of SOL-116 in healthy subjects and adult RA patients (Parts 1 and 2) and multiple SC doses in healthy subjects (Part 3). T... | [
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NCT05576012 | 8.3 | Study Assessments | 8.3 Study Assessments | [] |
NCT05576012 | 8.3.1 | Informed Consent | 8.3.1 Informed Consent After adequate explanation of the aims, methods, objectives of the study and potential hazards of the study drug and after the subject/patient has had ample time to consider their participation, a written informed consent from each individual participating in this study will be obtained. | [] |
NCT05576012 | 8.3.2 | Medical History and Baseline Demographics | 8.3.2 Medical History and Baseline Demographics All relevant medical history will be documented. Baseline demographics including sex, age, race and ethnicity will be recorded. | [] |
NCT05576012 | 8.3.2.1 | Baseline Symptoms | 8.3.2.1 Baseline Symptoms A baseline symptom is defined as an event that occurs between subject's signing of the informed consent form until the first administration of the study drug. Such events are not AEs and will be recorded as baseline symptoms in the Medical History Log in the eCRF. | [] |
NCT05576012 | 8.3.2.2 | RA Medical History, DAS28-CRP, and DAS28-ESR (RA Patients Only) | 8.3.2.2 RA Medical History, DAS28-CRP, and DAS28-ESR (RA Patients Only) The following information will be noted at Screening: Year of diagnosis, joints affected at diagnosis and present, rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies positivity (positive or negative), disease activity at diagn... | [] |
NCT05576012 | 8.3.2.3 | Prior and Concomitant Medications | 8.3.2.3 Prior and Concomitant Medications All relevant medications taken from 2 weeks prior to Screening (4 weeks for RA cohort) until end-of-study (EOS) or started during the study will be recorded on the Concomitant Medications page. For RA cohort, see also Section 8.3.2.2. Concomitant Medications initiated, stopped,... | [] |
NCT05576012 | 8.3.3 | Pharmacokinetic Assessments | 8.3.3 Pharmacokinetic Assessments | [] |
NCT05576012 | 8.3.3.1 | Timing for Sampling | 8.3.3.1 Timing for Sampling Table 5-1, Table 5-2 and Table 5-3 provide an overview of all PK blood sampling time points. | [] |
NCT05576012 | 8.3.3.2 | Procedures for Sampling | 8.3.3.2 Procedures for Sampling About 4.0 mL blood for the PK samples will be collected via vena puncture or via an intravenous (IV) catheter placed in a vein in the arm following the local standard procedures.  Information on equipment and further details on the procedures on the sampling are d... | [] |
NCT05576012 | 8.3.3.3 | Labeling | 8.3.3.3 Labeling PK tubes will be pre-labeled. | [] |
NCT05576012 | 8.3.3.4 | Shipping Procedures | 8.3.3.4 Shipping Procedures The site staff will take care of the shipment of the samples. Samples must be sent to QPS Netherlands B.V. laboratory at time intervals agreed with the Sponsor. The samples must be packed securely together with completed shipment forms in polystyrene-insulated shipping containers together wi... | [] |
NCT05576012 | 8.3.3.5 | Bioanalysis | 8.3.3.5 Bioanalysis The concentrations of SOL-116 in serum will be determined in the range 1-500 ng/mL (preliminary) using a validated ligand binding assay. Concentrations will be calculated by interpolation from a calibration curve. Quality control samples will be analyzed throughout the study. Their measured concentr... | [] |
NCT05576012 | 8.3.4 | Safety and Tolerability Assessments | 8.3.4 Safety and Tolerability Assessments The definitions, reporting, and follow-up of AEs and serious adverse events (SAEs) are described in Section 9. Table 5-1, Table 5-2 and Table 5-3 provide an overview of all time points on which safety assessments will be performed. | [] |
NCT05576012 | 8.3.4.1 | Adverse Events | 8.3.4.1 Adverse Events Adverse events will be recorded according to the local standard operating procedure (SOP)/Work instruction of the clinic. | [] |
NCT05576012 | 8.3.4.2 | Vital Signs | 8.3.4.2 Vital Signs Vital sign assessments will be performed according to the local SOP of the clinic and will include measurements of supine blood pressure, pulse rate, and body temperature. Vital sign measurements will be collected after the subject/patient has been resting for 5 minutes in a supine position. | [] |
NCT05576012 | 8.3.4.3 | Body Weight and Height | 8.3.4.3 Body Weight and Height The subject's/patient's body weight will be measured using a validated balance according to the local SOP of the clinic. Body weight will be recorded with 1 decimal. The subject's/patient's height is measured without wearing shoes. The body mass index (BMI) will be calculated from the wei... | [] |
NCT05576012 | 8.3.4.4 | 12-lead ECG | 8.3.4.4 12-lead ECG Subjects/patients will be in a supine position for 5 minutes prior to the measurements. ECGs will be evaluated and classified as normal/abnormal according to the local SOP of the clinic. In case of "abnormal", the abnormality has to be described. The Investigator will judge if the abnormal ECG findi... | [] |
NCT05576012 | 8.3.4.5 | Physical Examination | 8.3.4.5 Physical Examination Physical examination will be performed consisting of inspection, percussion, palpation, and auscultation according to the local SOP of the clinic. For Part 2, this will also (at baseline) include a 28-joint status (number of swollen joints and number of tender joints). Clinically relevant f... | [] |
NCT05576012 | 8.3.4.6 | Patient Global Health VAS Score (Part 2 Only) | 8.3.4.6 Patient Global Health VAS Score (Part 2 Only) In Part 2, the patients will be asked (at baseline) to fill in a Patient Global Health VAS score. | [] |
NCT05576012 | 8.3.4.7 | 3-lead ECG (Telemetry) | 8.3.4.7 3-lead ECG (Telemetry) Telemetry monitoring will be set on alarm and used for evaluation of any cardiac event. It will be performed according to the local SOP of the clinic. Results will be analyzed by the Investigator and significant findings will be reported. Clinically significant abnormal findings (as judge... | [] |
NCT05576012 | 8.3.4.8 | QuantiFERON® Test | 8.3.4.8 QuantiFERON® Test The QuantiFERON® test will be performed at Screening to test for active tuberculosis (TB) or latent TB unless this assessment was done within 3 weeks prior to dosing and results are available. Applicable for RA patients only: in case of rescreening within three months after Screening, negative... | [] |
NCT05576012 | 8.3.4.9 | Chest X-ray (RA Patients Only) | 8.3.4.9 Chest X-ray (RA Patients Only) Only for RA patients, a chest X-ray will be taken at Screening to test for active TB or latent TB. If a chest X-ray was performed within the past three weeks prior to dosing and documentation is available, it is not necessary to repeat the chest X-ray. In case of rescreening withi... | [] |
NCT05576012 | 8.3.4.10 | Injection Site Reactions | 8.3.4.10 Injection Site Reactions Injection site reactions (dryness, redness, swelling, pain/tenderness and itching) will be assessed by the Investigator at specific time points (see Table 5-1, Table 5-2 and Table 5-3). Clinically significant abnormal findings (as judged by the Investigator) will be recorded as AE. | [] |
NCT05576012 | 8.3.4.11 | Laboratory Assessments | 8.3.4.11 Laboratory Assessments Clinically significant laboratory abnormalities must be reported by the Investigator as AE or SAE as appropriate (see Section 9). At Screening, laboratory assessments may be repeated once, at the discretion of the Investigator. For Part 1 and 2, the blood samples will be taken under fast... | [] |
NCT05576012 | 8.3.4.12 | Drug and Cotinine Screen | 8.3.4.12 Drug and Cotinine Screen For a urine drug screening, the following compounds may be assessed: amphetamine, barbiturates, benzodiazepines, cocaine, marijuana (THC), MDMA/ecstasy, methadone, methamphetamine, morphine, opioids, phencyclidine, and tricyclic antidepressants. Template TSP820.014, effective date 01 M... | [] |
NCT05576012 | 8.3.4.13 | Alcohol Test | 8.3.4.13 Alcohol Test An alcohol test (breath test or urine) will be performed according to the local SOP of the clinic. | [] |
NCT05576012 | 8.3.4.14 | Pregnancy Test | 8.3.4.14 Pregnancy Test A serum pregnancy test will be performed at Screening. A urine pregnancy test will be performed on Day -1, Visit 7 (Parts 1 and 3), Visit 8 (Part 3) and Visit 9 (Parts 2 and 3) and at the EOS examination (or at early termination) (all parts). The results must be available prior to dosing. | [] |
NCT05576012 | 8.3.4.15 | Serology | 8.3.4.15 Serology At Screening, virus serology will be assessed (HIV, hepatitis B and hepatitis C). | [] |
NCT05576012 | 8.3.4.16 | SARS-CoV-2 Test | 8.3.4.16 SARS-CoV-2 Test COVID-19 testing will be performed at the time point described in Table 5-1. A check on health status will be performed and body temperature will be measured before the subject/patient enters the clinic on Day -1 (Part 1). For Parts 2 and 3, COVID-19 testing is not mandatory as recommendations ... | [] |
NCT05576012 | 8.3.5 | Immunogenicity | 8.3.5 Immunogenicity Blood samples will be taken to check for the presence of ADA at time points specified in Table 5-1, Table 5-2 and Table 5-3. About 3.5 mL blood for the ADA samples will be collected via vena puncture or via an IV catheter placed in a vein in the arm following the local standard procedures. | [] |
NCT05576012 | 8.3.6 | Exploratory Assessments | 8.3.6 Exploratory Assessments Blood samples will be taken to check BSSL concentration, cytokine/chemokine panel (including but not limited to IFNγ, IL-1β, IL-6, IL-10, IL-12, IL-18, MCP-1, and TNFα), flow cytometry panel (only RA patients), and whole blood stimulation (only RA patients) at the time points specified in ... | [] |
NCT05576012 | 8.3.6.1 | Exploratory Samples (Future Analysis) | 8.3.6.1 Exploratory Samples (Future Analysis) At time points specified in Table 5-1, Table 5-2 and Table 5-3, extra blood samples (5.5 mL in total) will be taken for future exploratory analysis of potential PK and/or PD markers of relevance for SOL-116. The samples will be discarded at the latest 10 years after the sam... | [] |
NCT05576012 | 8.3.7 | Order of Assessments | 8.3.7 Order of Assessments In case several study procedures are scheduled at the same time point, the following sequence should be followed pre-dose: 12-lead ECG, vital signs, asking for AEs, PK blood sampling, blood sampling for immunogenicity, blood sampling for BSSL, blood sampling for cytokine and chemokine panel, ... | [] |
NCT05576012 | 8.3.8 | Allowed Time Windows for PK, PD and Safety Assessments | 8.3.8 Allowed Time Windows for PK, PD and Safety Assessments Table 8-2: Allowed Time Windows | (Part 2 only), blood sampling for whole blood stimulation assay (Part 2 only), blood samplingfor future exploratory analysis, blood sampling for clinical laboratory tests, 12-lead ECG3-lead ECGbe reserved for all assessments ... | [] |
NCT05576012 | 8.3.9 | Total Blood Volume | 8.3.9 Total Blood Volume Table 8-3: Blood Volume (Part 1) | Total Blood Volume8.3.9 | | | The total volume of blood to be taken per subject/patient during the entire course of the study | |-------------------------------------------------------------------------------------------|------------|------------|-------------... | [] |
NCT05576012 | 8.4 | Study Population | 8.4 Study Population The subject population will include healthy adult subjects (Cohort 1-6? of Part 1 and multiple dosing cohorts in Part 3) and patients (Cohort 7, Part 2) who satisfy all entry criteria. | [] |
NCT05576012 | 8.4.1 | Inclusion Criteria | 8.4.1 Inclusion Criteria The following criteria must be met by all subjects/patients considered for study participation: - 1. Willing and able to give written informed consent for participation in the study and is willing and able to abide by the study restrictions. - 2. Males and females aged between 18 and 65 years (... | [] |
NCT05576012 | 8.4.2 | Exclusion Criteria | 8.4.2 Exclusion Criteria Subjects/Patients will be excluded if they meet any of the following criteria: - 1. History of any clinically significant acute inflammatory joint disease (for the RA cohort; other than RA). - 2. Any chronic or long-lasting disease which may interfere with the study objectives or jeopardise the... | [] |
NCT05576012 | 8.4.3 | Diet, Activities, and Other Restrictions | 8.4.3 Diet, Activities, and Other Restrictions | [] |
NCT05576012 | 8.4.3.1 | Concomitant Medication | 8.4.3.1 Concomitant Medication From 2 weeks (or 28 days if the drug is a potential hepatic enzyme inducer) or 5 half-lives (whichever is longer) prior to Screening (or 4 weeks for RA cohort) until the EOS, prescribed or over-the-counter medication (including herbal remedies) is only allowed as described in exclusion cr... | [] |
NCT05576012 | 8.4.3.2 | Alcohol | 8.4.3.2 Alcohol Drinking of alcoholic beverages is not permitted from 48 hours prior to each clinic visit or while in the clinic. | [] |
NCT05576012 | 8.4.3.3 | Physical Activities | 8.4.3.3 Physical Activities From 24 hours prior to each clinic visit, the subjects/patients should refrain from excessive physical exercise and strenuous sports activities (endurance sports). | [] |
NCT05576012 | 8.4.3.4 | Dietary Aspects | 8.4.3.4 Dietary Aspects Consumption of food containing poppy seeds is not allowed from 24 hours prior to Screening and prior to Day -1. | [] |
NCT05576012 | 8.4.3.5 | Smoking | 8.4.3.5 Smoking Smoking is not permitted from one month prior to Screening up to and including the EOS visit. | [] |
NCT05576012 | 8.4.3.6 | Participation in Other Clinical Studies | 8.4.3.6 Participation in Other Clinical Studies Study subjects are not allowed to participate in any other interventional clinical drug study during the study period.  | [] |
NCT05576012 | 8.5 | Study Drugs | 8.5 Study Drugs Study drugs include the investigational drug SOL-116 and matching placebo administered during the study. | [] |
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