protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT03023826 | 10.1 | Sample Size Determination | 10.1. Sample Size Determination Up to approximately 24 healthy subjects may be enrolled to ensure that at least 20 subjects complete the study. This sample size is based on a calculation of precision of the estimated ratio of area under the concentration versus time curve (AUCs).  At the discret... | [] |
NCT03023826 | 10.2 | Populations for Analyses | 10.2. Populations for Analyses | [] |
NCT03023826 | 10.2.1 | Study Participant Disposition | 10.2.1. Study Participant Disposition A detailed description of subject disposition will be provided at the end of the study. | [] |
NCT03023826 | 10.2.2 | Study Participant Characteristics | 10.2.2. Study Participant Characteristics The subject's age, sex, weight, height, BMI, race, and other demographic characteristics will be recorded and summarized using descriptive statistics. | [] |
NCT03023826 | 10.3 | Statistical Analyses | 10.3. Statistical Analyses Statistical analysis of this study will be the re sponsibility of Eli Lilly and Company or its designee. Pharmacokinetic analyses will be conducted on the full analysis set. This set includes all data from all subjects receiving at least 1 dose of LY3202626, according to the dose administrati... | [] |
NCT03023826 | 10.3.1 | Safety Analyses | 10.3.1. Safety Analyses | [] |
NCT03023826 | 10.3.1.1 | Clinical Evaluation of Safety | 10.3.1.1. Clinical Evaluation of Safety All investigational product and protocol procedure AEs will be listed, and if the frequency of events allows, safety data will be summarized using descriptive methodology. The incidence of symptoms for each dose administration will be presented by severity and by association with... | [] |
NCT03023826 | 10.3.1.2 | Statistical Evaluation of Safety | 10.3.1.2. Statistical Evaluation of Safety Safety parameters that will be assessed include safety lab parameters and vital signs. The parameters and changes from baseline (check-in), where appropriate, will be listed and summarized using standard descriptive statistics. Additional analysis will be performed if warrante... | [] |
NCT03023826 | 10.3.2 | Pharmacokinetic Analyses | 10.3.2. Pharmacokinetic Analyses | [] |
NCT03023826 | 10.3.2.1 | Pharmacokinetic Parameter Estimation | 10.3.2.1. Pharmacokinetic Parameter Estimation Pharmacokinetic parameter estimates for LY3202626 will be calculated by standard noncompartmental methods of analysis. The primary parameters for analysis will be Cmax, AUC from time zero to infinity (AUC0-∞), AUC from time zero to time t, where t is the last time point wi... | [] |
NCT03023826 | 10.3.2.2 | Pharmacokinetic Statistical Inference | 10.3.2.2. Pharmacokinetic Statistical Inference Pharmacokinetic parameter estimates will be evaluated to delineate relative bioavailability and food effects. The following comparisons will be interests of statistical analysis of PK parameters: - relative bioavailability: LY3202626 T1-12 fasted (test) versus LY3202626 R... | [] |
NCT03023826 | 10.3.3 | Pharmacodynamic Analysis | 10.3.3. Pharmacodynamic Analysis | [] |
NCT03023826 | 10.3.3.1 | Pharmacodynamic Parameter Estimation | 10.3.3.1. Pharmacodynamic Parameter Estimation Plasma concentrations of Aβ1-40 and Aβ1-42 will be summarized for each treatment based on the nadir concentration (Cnadir), the time to reach Cnadir (tnadir), and the 24-hour average values expressed as percentage change from baseline. | [] |
NCT03023826 | 10.3.3.2 | Pharmacodynamic Statistical Inference | 10.3.3.2. Pharmacodynamic Statistical Inference No formal statistical testing will be conducted. | [] |
NCT03023826 | 10.3.4 | Interim Analyses | 10.3.4. Interim Analyses No interim analyses are planned for this study. If an unplanned interim analysis is deemed necessary, the Lilly CP, CRP/investigator, or designee will consult with the appropriate medical director or designee to determine if it is necessary to amend the protocol. | [] |
NCT03023826 | 11 | References | 11. References Shankar GM, Li S, Mehta TH, Garcia-Munoz A, Shepardson NE, Smith I, Brett FM, Farrell MA, Rowan MJ, Lemere CA, Regan CM, Walsh DM, Sabatini BL, Selkoe DJ. Amyloid-beta protein dimers isolated directly from Alzheimer's brains impair synaptic plasticity and memory. Nat Med. 2008;14(8):837-842. FDA. US Depa... | [
"Appendix 1. Abbreviations and Definitions",
"Appendix 2. Clinical Laboratory Tests",
"Laboratory Tests",
"Appendix 3. Study Governance, Regulatory and Ethical Considerations",
"Informed Consent",
"Ethical Review",
"Regulatory Considerations",
"Protocol Signatures",
"Final Report Signature",
"Data... |
NCT03053622 | 1 | Protocol Synopsis | 1. Protocol Synopsis
Title of Study: A Phase 1, Single-Dose Study to Assess the Relative Bioavailability, Absolute Bioavailability, and Tolerability of LY3074828 Formulations in Healthy Subjects
Rationale: Study I6T-MC-AMAL (AMAL) is a Phase 1 study designed to compare the formulation of LY3074828 previously used in ... | [
"Title of Study:",
"Rationale:",
"Objective(s)/Endpoints:",
"Summary of Study Design:",
"Treatment Arms and Duration:",
"Number of Subjects:",
"Statistical Analysis:"
] |
NCT03053622 | 2 | Schedule of Activities | 2. Schedule of Activities Study Schedule Protocol I6T-MC-AMAL | | Screening | -1 | 1 | 2 | 4 | 8 | 11a | 15 | 22 | 29 | 43 | 57 | 71 | 85 | | | |----------------------------------------------------------------|-----------|----|----------------------------------------------|----|-----|-----|-----|-----------------|-----... | [] |
NCT03053622 | 3 | Introduction | 3.Introduction | [] |
NCT03053622 | 3.1 | Study Rationale | 3.1. Study Rationale  Study I6T-MC-AMAL (AMAL) is a Phase1 study designed to determine whether the pharmacokinetics (PK) and tolerability of LY3074828 are affected following these changes to the investigational product, when administered subcutaneously to healthy subjects. The potential effect of... | [] |
NCT03053622 | 3.2 | Background | 3.2. Background Interleukin-23(IL-23), a member of the interleukin-12 (IL-12)family of cytokines, is a heterodimeric protein composed of 2subunits: the p40 subunit, which IL-23 shares with IL-12, and the p19 subunit, which is believed to be specific to IL-23. Interleukin-23is produced by antigen-presenting cells, such ... | [] |
NCT03053622 | 3.3 | Benefit/Risk Assessment | 3.3. Benefit/Risk Assessment Based on LY3074828 nonclinical and preliminary clinical data, there are no anticipated risks requiring monitoring beyond those of a typical humanized monoclonal antibody in human studies. No clinically significant safety or tolerability concerns have been identified in patients or subjects ... | [] |
NCT03053622 | 4 | Objectives and Endpoints | 4. Objectives and Endpoints Table [AMAL.1](#page-17-1) shows the objectives and endpoints of the study. Table AMAL.1. Objectives and Endpoints | Objectives | Endpoints | |-----------------------------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT03053622 | 5 | Study Design | 5. Study Design | [] |
NCT03053622 | 5.1 | Overall Design | 5.1. Overall Design Study AMAL is a single-center, randomized, parallel-treatment, open-label, Phase 1 single-dose administration study evaluating LY3074828 in 72 healthy subjects. Screening Period (≤4 weeks): Subjects will be evaluated for study eligibility ≤28 days prior to enrollment. Residential Period (2 days): Su... | [] |
NCT03053622 | 5.2 | Number of Participants | 5.2. Number of Participants A total of 72 subjects will be enrolled to ensure that approximately 64 subjects complete the study (16 completers per treatment). From a data standpoint, a subject's study participation is considered as complete if he/she received the study drug and completes all activities up to and includ... | [] |
NCT03053622 | 5.3 | End of Study Definition | 5.3. End of Study Definition End of the study is the date of the last visit or last scheduled procedure shown in the Schedule of Activities (Section [2\)](#page-10-0) for the last subject. | [] |
NCT03053622 | 5.4 | Scientific Rationale for Study Design | 5.4. Scientific Rationale for Study Design Single doses of 250 mg LY3074828 and the PK sampling timepoints have been selected to generate PK profiles sufficient to fulfill the study objectives. As the primary endpoints are PK-related and therefore considered to be objective in nature, it is not considered appropriate t... | [] |
NCT03053622 | 5.5 | Justification for Dose | 5.5. Justification for Dose CCI Doses up to 1200mg were found to be safe when administered by IV infusion in healthy subjects in the single-dose Study AMAD. Subcutaneous bioavailability was approximately40%in StudyAMAA. The margin of safety for the dose of 250mg IVrelative to the no-observed-adverse-effect level observ... | [] |
NCT03053622 | 6 | Study Population | 6. Study Population Eligibility of subjects for study enrollment will be based on the results of screening medical history, physical examination/medical assessment, vital signs, clinical laboratory tests, and ECG. The nature of any conditions present at the time of the physical examination and any preexisting condition... | [] |
NCT03053622 | 6.1 | Inclusion Criteria | 6.1. Inclusion Criteria Subjects are eligible for inclusion in the study only if they meet all of the following criteria at screening and/or enrollment: - [1] are overtly healthy males or females, as determined by medical history and physical examination - [1a] male subjects: - agree to not donate sperm for the duratio... | [
"[1b] female subjects:"
] |
NCT03053622 | 6.2 | Exclusion Criteria | 6.2. Exclusion Criteria Subjects will be excluded from study enrollment if they meet any of the following criteria at screening and/or enrollment: - [8] are investigative site personnel directly affiliated with this study and their immediate families. Immediate family is defined as a spouse, biological or legal guardia... | [] |
NCT03053622 | 6.3 | Lifestyle and/or Dietary Requirements | 6.3. Lifestyle and/or Dietary Requirements Throughout the study, subjects may undergo medical assessments and review of compliance with requirements before continuing in the study. | [] |
NCT03053622 | 6.3.1 | Meals and Dietary Restrictions | 6.3.1. Meals and Dietary Restrictions Subjects should fast overnight for at least 8 hours before dosing (water permitted). | [] |
NCT03053622 | 6.3.2 | Caffeine, Alcohol, and Tobacco | 6.3.2. Caffeine, Alcohol, and Tobacco Subjects should not be allowed caffeine consumption for 12 hours prior to CRU admission and when in the CRU. At other times during the outpatient period, subjects will be allowed to maintain their regular caffeine consumption. Alcohol consumption is not allowed from 12 hours prior ... | [] |
NCT03053622 | 6.3.3 | Poppy Seeds | 6.3.3. Poppy Seeds Foods and beverages containing poppy seeds will not be allowed from 7 days prior to screening until final discharge from the study. | [] |
NCT03053622 | 6.3.4 | Activity | 6.3.4. Activity Subjects will be advised to maintain their regular levels of physical activity/exercise during the study, but refrain from vigorous exercise. Strenuous activity should be avoided from 24 hours prior to admission until discharge from the CRU. When certain study procedures are in progress at the site, sub... | [] |
NCT03053622 | 6.4 | Screen Failures | 6.4. Screen Failures Subjects who do not meet the criteria for participation in this study (screen failure) may not be rescreened. | [] |
NCT03053622 | 7 | Treatment | 7. Treatment | [] |
NCT03053622 | 7.1 | Treatment Administered | 7.1. Treatment Administered The proposed LY3074828 test formulation will be prepared extemporaneously as sterile solutions for SC injection and IV infusion, as described in the pharmacy instructions provided by the sponsor to the site. The clinical material for extemporaneous preparation will be supplied as a frozen so... | [] |
NCT03053622 | 7.1.1 | Packaging and Labeling | 7.1.1. Packaging and Labeling LY3074828 will be supplied to the investigator by Lilly. Clinical trial materials are manufactured in accordance with good manufacturing practices. All investigational products will be stored, inventoried, reconciled, and destroyed according to applicable regulations. LY3074828 reference f... | [] |
NCT03053622 | 7.2 | Method of Treatment Assignment | 7.2. Method of Treatment Assignment Subjects will be randomized to 1 of 4 treatments using a computer-generated allocation schedule. | [] |
NCT03053622 | 7.2.1 | Timing of Doses | 7.2.1. Timing of Doses The actual time of all dose administrations will be recorded in the subject's electronic case report form (eCRF). | [] |
NCT03053622 | 7.3 | Blinding | 7.3. Blinding This is an open-label study. | [] |
NCT03053622 | 7.4 | Dose Modification | 7.4. Dose Modification Dose adjustments are not permitted in this study. | [] |
NCT03053622 | 7.4.1 | Special Treatment Considerations | 7.4.1. Special Treatment Considerations | [] |
NCT03053622 | 7.4.1.1 | Premedication for Infusions | 7.4.1.1. Premedication for Infusions Premedication for the subjects randomized to receive LY3074828 as an IV infusion is not planned. However, if an infusion reaction occurs, appropriate medication may be used as determined by the study investigator(s) and documented in the eCRF. If one Grade 2 infusion reaction is obs... | [] |
NCT03053622 | 7.4.1.2 | Management of Infusion Reactions | 7.4.1.2. Management of Infusion Reactions Due to the risk of an infusion reaction with any biological agent, all subjects should be monitored closely. Symptoms and signs that may occur as part of an infusion reaction include, but are not limited to, fever, chills, nausea, headache, bronchospasm, hypotension, angioedema... | [] |
NCT03053622 | 7.4.1.3 | Safety Protocol in the Event of a Retrospective Positive Sterility Finding from extemporaneously prepared study treatment | 7.4.1.3. Safety Protocol in the Event of a Retrospective Positive Sterility Finding from extemporaneously prepared study treatment If a positive sterility finding were to arise in the terminally sterile filtered product, the subjects who were dosed from the impacted batch should be immediately contacted and asked to re... | [] |
NCT03053622 | 7.5 | Preparation/Handling/Storage/Accountability | 7.5. Preparation/Handling/Storage/Accountability Only participants enrolled in the study may receive investigational product and only authorized site staff may supply or administer study treatment. All study treatments should be stored in an environmentally controlled and monitored (manual or automated) area in accorda... | [] |
NCT03053622 | 7.6 | Treatment Compliance | 7.6. Treatment Compliance The investigational product will be administered at the clinical site, and documentation of treatment administration will occur at the site. | [] |
NCT03053622 | 7.7 | Concomitant Therapy | 7.7. Concomitant Therapy Over-the-counter or prescription medication, including herbal medications such as St. John's Wort, are not permitted within 14 days prior to dosing and throughout the study. However, stable doses of oral contraceptive or hormone replacement therapy may be allowed as per judgment of the investig... | [] |
NCT03053622 | 7.8 | Treatment after the End of the Study | 7.8. Treatment after the End of the Study Not applicable for this study. | [] |
NCT03053622 | 8 | Discontinuation Criteria | 8. Discontinuation Criteria | [] |
NCT03053622 | 8.1 | Discontinuation from Study Treatment | 8.1. Discontinuation from Study Treatment The reason for and date of discontinuation will be collected for all subjects. All randomized subjects who discontinue after receiving study drug will have ED procedures performed as shown in the Schedule of Activities (Section [2\)](#page-10-0). | [] |
NCT03053622 | 8.1.1 | Discontinuation of Inadvertently Enrolled Subjects | 8.1.1. Discontinuation of Inadvertently Enrolled Subjects If the Sponsor or investigator identifies a subject who did not meet enrollment criteria and was inadvertently enrolled, the subject will be discontinued from the study and ED assessments will be performed as described in the Schedule of Activities (Section [2\)... | [] |
NCT03053622 | 8.2 | Discontinuation from the Study | 8.2. Discontinuation from the Study Subjects will be discontinued in the following circumstances: - Enrollment in any other clinical trial involving an investigational product or enrollment in any other type of medical research judged not to be scientifically or medically compatible with this study - Participation in t... | [] |
NCT03053622 | 8.3 | Subjects Lost to Follow-up | 8.3. Subjects Lost to Follow-up A subject will be considered lost to follow-up if he or she repeatedly fails to return for scheduled visits and is unable to be contacted by the study site. Site personnel are expected to make diligent attempts to contact subjects who fail to return for a scheduled visit or were otherwis... | [] |
NCT03053622 | 9 | Study Assessments and Procedures | 9. Study Assessments and Procedures Section [2](#page-10-0) lists the Schedule of Activities, detailing the study procedures and their timing (including tolerance limits for timing). [Appendix 2](#page-50-0) lists the clinical laboratory tests that will be performed for this study. [Appendix 4](#page-54-0) provides a s... | [] |
NCT03053622 | 9.1 | Efficacy Assessments | 9.1. Efficacy Assessments This section is not applicable for this study. | [] |
NCT03053622 | 9.2 | Adverse Events | 9.2. Adverse Events Investigators are responsible for monitoring the safety of subjects who have entered this study and for alerting Lilly or its designee to any event that seems unusual, even if this event may be considered an unanticipated benefit to the subject. The investigator is responsible for the appropriate me... | [] |
NCT03053622 | 9.2.1 | Serious Adverse Events | 9.2.1. Serious Adverse Events An SAE is any AE from this study that results in one of the following: - death - initial or prolonged inpatient hospitalization - a life-threatening experience (that is, immediate risk of dying) - persistent or significant disability/incapacity - congenital anomaly/birth defect - important... | [] |
NCT03053622 | 9.2.1.1 | Suspected Unexpected Serious Adverse Reactions | 9.2.1.1. Suspected Unexpected Serious Adverse Reactions Suspected unexpected serious adverse reactions (SUSARs) are serious events that are not listed in the IB and that the investigator identifies as related to investigational product or procedure. United States 21 CFR 312.32 and European Union Clinical Trial Directiv... | [] |
NCT03053622 | 9.2.2 | Complaint Handling | 9.2.2. Complaint Handling Lilly collects product complaints on investigational products and drug delivery systems used in clinical trials in order to ensure the safety of study participants, monitor quality, and to facilitate process and product improvements. Subjects should be instructed to contact the investigator as... | [] |
NCT03053622 | 9.3 | Treatment of Overdose | 9.3. Treatment of Overdose For the purposes of this study, an overdose of LY3074828 is considered any dose higher than the dose assigned through randomization. There is no specific antidote for LY3074828. In the event of an overdose, the subject should receive appropriate supportive care and any AEs should be documente... | [] |
NCT03053622 | 9.4 | Safety | 9.4. Safety | [] |
NCT03053622 | 9.4.1 | Laboratory Tests | 9.4.1. Laboratory Tests For each subject, clinical laboratory tests detailed in [Appendix 2](#page-50-0) should be conducted according to the Schedule of Activities (Section [2\)](#page-10-0). | [] |
NCT03053622 | 9.4.2 | Vital Signs | 9.4.2. Vital Signs For each subject, vital signs measurements should be conducted according to the Schedule of Activities (Section [2\)](#page-10-0) and following the study-specific recommendations included in the Manual of Operations for the study. Additional vital signs may be assessed as clinically indicated as well... | [] |
NCT03053622 | 9.4.3 | Electrocardiograms | 9.4.3. Electrocardiograms For each subject, ECGs should be collected according to the Schedule of Activities (Section [2\)](#page-10-0) and following the study-specific recommendations included in the Manual of Operations for the study. Any clinically significant findings from ECGs that result in a diagnosis and that o... | [] |
NCT03053622 | 9.4.4 | Tuberculosis Testing | 9.4.4. Tuberculosis Testing Subjects will be tested as indicated in the Schedule of Activities (Section [2\)](#page-10-0) for evidence of active or latent TB using the QuantiFERON-TB Gold test. If the test is indeterminate, 1 retest is allowed. If the retest is indeterminate, then the subject is excluded from the study... | [] |
NCT03053622 | 9.4.5 | Safety Monitoring | 9.4.5. Safety Monitoring The Lilly clinical pharmacologist or clinical research physician/scientist will monitor safety data throughout the course of the study. Lilly will review SAEs within time frames mandated by company procedures. The Lilly clinical pharmacologist or research physician will consult with the functio... | [] |
NCT03053622 | 9.4.6 | Injection / Infusion-Site Assessments | 9.4.6. Injection / Infusion-Site Assessments Local tolerability at the injection or infusion site will be evaluated for erythema, induration, categorical pain, pruritus, and edema as indicated in the Section [2](#page-10-0) and reported in the CRF. If one or more symptom(s) of an injection/infusion site reaction is rep... | [] |
NCT03053622 | 9.4.7 | Immunogenicity Assessments | 9.4.7. Immunogenicity Assessments Blood samples for immunogenicity testing will be collected to determine antibody production against the investigational product as specified in the Schedule of Activities (Section [2\)](#page-10-0). A risk-based approach will be used to monitor subjects who develop TE-ADAs during and f... | [] |
NCT03053622 | 9.5 | Pharmacokinetics | 9.5. Pharmacokinetics At the visits and times specified in the Schedule of Activities (Section [2\)](#page-10-0), venous blood samples will be collected to determine the serum concentrations of LY3074828. A maximum of 3 samples may be collected at additional time points during the study if warranted and agreed upon bet... | [] |
NCT03053622 | 9.5.1 | Bioanalysis | 9.5.1. Bioanalysis Samples will be analyzed at a laboratory approved by the sponsor and stored at a facility designated by the sponsor. Concentrations of LY3074828 will be assayed using a validated enzyme-linked immunosorbent assay (ELISA). Bioanalytical samples collected to measure investigational product concentratio... | [] |
NCT03053622 | 9.6 | Pharmacodynamics | 9.6. Pharmacodynamics Not applicable. | [] |
NCT03053622 | 9.7 | Genetics | 9.7. Genetics A blood sample will be collected for pharmacogenetic analysis as specified in the Schedule of Activities (Section [2\)](#page-10-0), where local regulations allow. Samples will not be used to conduct unspecified disease or population genetic research either now or in the future. Samples will be used to in... | [] |
NCT03053622 | 9.8 | Biomarkers | 9.8. Biomarkers This section is not applicable for this study. | [] |
NCT03053622 | 9.9 | Health Economics | 9.9. Health Economics This section is not applicable for this study. | [] |
NCT03053622 | 10 | Statistical Considerations and Data Analysis | 10. Statistical Considerations and Data Analysis | [] |
NCT03053622 | 10.1 | Sample Size Determination | 10.1. Sample Size Determination A total of 72 subjects will be enrolled to ensure that approximately 64 subjects complete the study (16 completers per treatment). The estimated total variability (coefficient of variation) in AUC from time zero to infinity (AUC[0-∞]), AUC from time zero to time t, where t is the last sa... | [] |
NCT03053622 | 10.2 | Populations for Analyses | 10.2. Populations for Analyses | [] |
NCT03053622 | 10.2.1 | Study Participant Disposition | 10.2.1. Study Participant Disposition A detailed description of subject disposition will be provided at the end of the study. | [] |
NCT03053622 | 10.2.2 | Study Participant Characteristics | 10.2.2. Study Participant Characteristics The subject's age, sex, weight, BMI, height, race/subrace, or other demographic characteristics will be recorded and summarized by treatment as well as overall. | [] |
NCT03053622 | 10.3 | Statistical Analyses | 10.3. Statistical Analyses Statistical analysis of this study will be the responsibility of Eli Lilly and Company or its designee. Pharmacokinetic analyses will be conducted on the full analysis set. This set includes all data from all subjects receiving a dose of LY3074828, with evaluable PK data, according to the tre... | [] |
NCT03053622 | 10.3.1 | Safety Analyses | 10.3.1. Safety Analyses | [] |
NCT03053622 | 10.3.1.1 | Clinical Evaluation of Safety | 10.3.1.1. Clinical Evaluation of Safety All investigational product and protocol procedure AEs will be listed, and if the frequency of events allows, safety data will be summarized using descriptive methodology. The incidence of symptoms for each treatment will be presented by severity and by association with investiga... | [] |
NCT03053622 | 10.3.1.2 | Statistical Evaluation of Safety | 10.3.1.2. Statistical Evaluation of Safety Safety parameters that will be assessed include safety laboratory parameters, vital signs, and ECG parameters. The parameters, and changes from baseline (predose) where appropriate, will be listed, and summarized using standard descriptive statistics. Additional analysis will ... | [] |
NCT03053622 | 10.3.2 | Pharmacokinetic Analyses | 10.3.2. Pharmacokinetic Analyses | [] |
NCT03053622 | 10.3.2.1 | Pharmacokinetic Parameter Estimation | 10.3.2.1. Pharmacokinetic Parameter Estimation Pharmacokinetic parameter estimates for LY3074828 will be calculated by standard noncompartmental methods of analysis. The primary parameters for analysis will be AUC(0-∞) and AUC(0-tlast) of LY3074828. The secondary parameters for analysis will be Cmax and time to Cmax (t... | [] |
NCT03053622 | 10.3.2.2 | Pharmacokinetic Statistical Inference | 10.3.2.2. Pharmacokinetic Statistical Inference Pharmacokinetic parameter estimates will be evaluated to delineate effects of LY3074828 formulation when administered to healthy subjects by SC injection (Reference and Test SC 2 × 1-mL). Log-transformed Cmax, AUC(0-∞), and AUC(0-tlast) estimates will be evaluated in a li... | [] |
NCT03053622 | 10.3.3 | Pharmacodynamic Analyses | 10.3.3. Pharmacodynamic Analyses Not applicable. | [] |
NCT03053622 | 10.3.4 | Pharmacokinetic/Pharmacodynamic Analyses | 10.3.4. Pharmacokinetic/Pharmacodynamic Analyses Not applicable. | [] |
NCT03053622 | 10.3.5 | Evaluation of Immunogenicity | 10.3.5. Evaluation of Immunogenicity The frequency of antibody formation to LY3074828 will be determined. Treatment-emergent ADAs are those that are induced or boosted by exposure to study drug, with a 4-fold increase in titer compared to baseline if ADAs were detected at baseline or a titer 2-fold greater than the min... | [] |
NCT03053622 | 10.3.6 | Interim Analyses | 10.3.6. Interim Analyses The Lilly study team and investigator will be unblinded. Data may be accessed and analyzed while the trial is ongoing, but no changes to the study design are planned. An assessment committee will not be formed. Interim analysis is scheduled to occur when safety and PK data through approximately... | [] |
NCT03053622 | 11 | References | 11. References - Andersson A, Kokkola R, Wefer J, Erlandsson-Harris H, Harris RA. Differential macrophage expression of IL-12 and IL-23 upon innate immune activation defines rat autoimmune susceptibility. J Leukoc Biol. 2004;76(6):1118-1124. - Cornelissen F, Asmawidjaja PS, Mus AM, Corneth O, Kikly K, Lubberts E. IL-23... | [
"Appendix 1. Abbreviations and Definitions",
"Appendix 2. Clinical Laboratory Tests",
"Laboratory Tests",
"Appendix 3. Study Governance, Regulatory and Ethical Considerations",
"Informed Consent",
"Ethical Review",
"Regulatory Considerations",
"Protocol Signatures",
"Final Report Signature",
"Data... |
NCT03141281 | 2 | Click despotism | 2. Click despotism
Building a New City GUIDE PARTICIPANT: Building more cities allows you to expand your nation's territory borders. It also allows you to create more buildings to research faster, collect more resources, build more wonders, and help towards a territory victory. Build a new city. Note the number of cit... | [
"Building a New City",
"New Workers",
"New Farms, Woodcutter's Camps & Mine",
"Caravans"
] |
NCT03141281 | 2 | Click caravan | 2. Click caravan SAY: Watch as the caravan connects the two cities. With this your wealth will increase. When you create more cities, create more caravans to connect them.
Military Level 2 GUIDE PARTICIPANT: Research Military Level 2 to unlock mounted units. New ranks in military research increases population camps an... | [
"Military Level 2",
"Stable & Mounted Units",
"Seige Factory & Catapults",
"Unit Upgrades",
"Attack Enemy City",
"Wonders",
"Game Completion",
"Saving Games",
"Exiting Games",
"Filling out Diary",
"Load Saved Game",
"IADL1 Training Protocol",
"Wifi Setup",
"AARP Driver Safety Course",
"O... |
NCT03167242 | 1 | Introduction | 1 Introduction | [] |
NCT03167242 | 1.1 | Background | 1.1 Background Malaria is one of the most important infectious diseases which threatens about 3.2 billion people, almost half of the world's population. Despite increasing international efforts for malaria control, in 2015, there were 214 million cases worldwide of malaria and 438 000 deaths according to the latest Wor... | [] |
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