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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: LY3041658 (IV); Drug: LY3041658 (SC); Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 54
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States, 90216
      • Parexel Early Phase Unit at Glendale
  • Maryland
    • Baltimore, Maryland, United States, 21225
      • PAREXEL-Phase 1 Baltimore Harbor Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY3041658 (IV); Single dose of LY3041658, administered as a slow intravenous (IV) infusion in escalating dose cohorts.	Drug: LY3041658 (IV); Administered as slow IV infusion
Experimental: LY3041658 (SC); Single dose of LY3041658 administered subcutaneously (SC).	Drug: LY3041658 (SC); Administered SC
Placebo Comparator: Placebo; Single dose of placebo (0.9% sodium chloride injection) administered as a slow IV infusion.	Drug: Placebo; Administered as slow IV infusion

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2014
• Primary Completion (Actual): February 11, 2017
• Study Completion (Actual): February 11, 2017

Study Registration Dates

• First Submitted: May 22, 2014
• First Submitted That Met QC Criteria: May 22, 2014
• First Posted (Estimate): May 28, 2014

Study Record Updates

• Last Update Posted (Actual): February 15, 2017
• Last Update Submitted That Met QC Criteria: February 14, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: antibody; autoimmune
• Other Study ID Numbers: 15164; I7P-MC-DSAA (Other Identifier: Eli Lilly and Company)