Safety Study of LY3041658 in Healthy Participants
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 2/16/2017 |
| Start Date: | June 16, 2014 |
| End Date: | February 11, 2017 |
A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3041658 in Healthy Subjects
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.
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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