Safety Study of LY3041658 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LY3041658 (SC); Drug: LY3041658 (IV); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02148627

I7P-MC-DSAA (Other Identifier)

15164

Details and patient eligibility

About

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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

54 participants in 3 patient groups, including a placebo group

LY3041658 (IV)

Experimental group

Description:

Single dose of LY3041658, administered as a slow intravenous (IV) infusion in escalating dose cohorts.

Treatment:

Drug: LY3041658 (IV)

LY3041658 (SC)

Experimental group

Description:

Single dose of LY3041658 administered subcutaneously (SC).

Treatment:

Drug: LY3041658 (SC)

Placebo

Placebo Comparator group

Description:

Single dose of placebo (0.9% sodium chloride injection) administered as a slow IV infusion.

Treatment:

Drug: Placebo