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Completed

NCT Number: NCT02148627

Safety Study of LY3041658 in Healthy Participants

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Parexel Early Phase Unit at Glendale, Glendale, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LY3041658 (SC)

Drug

Administered SC

LY3041658 (IV)

Drug

Administered as slow IV infusion

Placebo

Drug

Administered as slow IV infusion

Primary outcomes

  1. The Number of Participants with One or More Drug-Related Adverse Events

    Time frame: Baseline to study completion (Day 85)

Secondary outcomes

  1. Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY3041658

    Time frame: Predose through Day 85, at specified timepoints

  2. Pharmacokinetics: Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to Time of Last Measurable Concentration (tlast)

    Time frame: Predose through Day 85, at specified timepoints

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3041658 in Healthy Subjects

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
May 28, 2014
Registry last updated
Feb 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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