Safety Study of LY3041658 in Healthy Participants
A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3041658 in Healthy Subjects
2 other identifiers
interventional
54
1 country
2
Brief Summary
The main purpose of this study is to evaluate the safety of LY3041658 in healthy participants, including first generation Japanese. The study will also investigate how the drug is processed and affects key immune cells. Study participation will last 4 months. Protocol amended in January, 2016 to include first generation Japanese participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Jun 2014
Longer than P75 for phase_1 healthy
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2014
CompletedFirst Posted
Study publicly available on registry
May 28, 2014
CompletedStudy Start
First participant enrolled
June 16, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 11, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 11, 2017
CompletedFebruary 15, 2017
February 1, 2017
2.7 years
May 22, 2014
February 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Number of Participants with One or More Drug-Related Adverse Events
Baseline to study completion (Day 85)
Secondary Outcomes (2)
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY3041658
Predose through Day 85, at specified timepoints
Pharmacokinetics: Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to Time of Last Measurable Concentration (tlast)
Predose through Day 85, at specified timepoints
Study Arms (3)
LY3041658 (IV)
EXPERIMENTALSingle dose of LY3041658, administered as a slow intravenous (IV) infusion in escalating dose cohorts.
LY3041658 (SC)
EXPERIMENTALSingle dose of LY3041658 administered subcutaneously (SC).
Placebo
PLACEBO COMPARATORSingle dose of placebo (0.9% sodium chloride injection) administered as a slow IV infusion.
Interventions
Eligibility Criteria
You may qualify if:
- All:
- Body mass index (BMI) between 18.0 to 32.0 kilogram per square meter (kg/m²).
- Absolute neutrophil count at screening should be ≥1.8 and ≤7.2 x 10\^3/microliter (uL), inclusive.
- First-generation Japanese:
- Participant, biological parents, and biological grandparents must be of exclusive Japanese descent and born in Japan.
- Are 20 to 65 years of age, inclusive, at the time of initial screening.
You may not qualify if:
- \- Have received antibody-based biologic agents (marketed or investigational) within 3 months or 5 half lives (t1/2) of the drug (whichever is longer) prior to screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Parexel Early Phase Unit at Glendale
Glendale, California, 90216, United States
PAREXEL-Phase 1 Baltimore Harbor Hospital Center
Baltimore, Maryland, 21225, United States
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2014
First Posted
May 28, 2014
Study Start
June 16, 2014
Primary Completion
February 11, 2017
Study Completion
February 11, 2017
Last Updated
February 15, 2017
Record last verified: 2017-02