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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02148627

Enrollment

Registered

2014-05-28

Start date

2014-06-16

Completion date

2017-02-11

Last updated

2017-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

antibody, autoimmune

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.

Interventions

DRUGLY3041658 (SC)

Administered SC

DRUGLY3041658 (IV)

Administered as slow IV infusion

DRUGPlacebo

Administered as slow IV infusion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026