Safety Study of LY3041658 in Healthy Participants

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT02148627

Run by

Eli Lilly and Company

People needed

54

Starts

2014-06-16

Expected to finish

2017-02-11

Last updated by the study team

2017-02-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Parexel Early Phase Unit at Glendale — Glendale, California, United States
• PAREXEL-Phase 1 Baltimore Harbor Hospital Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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