Safety Study of LY3041658 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3041658 (IV); Drug: LY3041658 (SC); Drug: Placebo

• Registration Number: NCT02148627
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-22
• Study First Submitted QC: 2014-05-22
• Study First Posted: 2014-05-28
• Study Start: 2014-06-16
• Status Verified: 2017-02
• Primary Completion: 2017-02-11
• Study Completion: 2017-02-11
• Last Update Submitted: 2017-02-14
• Last Update Posted: 2017-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3041658 (IV)	LY3041658 (IV)	Single dose of LY3041658, administered as a slow intravenous (IV) infusion in escalating dose cohorts.
LY3041658 (SC)	LY3041658 (SC)	Single dose of LY3041658 administered subcutaneously (SC).
Placebo	Placebo	Single dose of placebo (0.9% sodium chloride injection) administered as a slow IV infusion.

Primary Outcome Measures

Name	Time	Method
The Number of Participants with One or More Drug-Related Adverse Events	Baseline to study completion (Day 85)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Parexel Early Phase Unit at Glendale; 🇺🇸 Glendale, California, United States

PAREXEL-Phase 1 Baltimore Harbor Hospital Center; 🇺🇸 Baltimore, Maryland, United States