A Study of LY3471851 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: LY3471851

• Registration Number: NCT04133116
• Lead Sponsor: Nektar Therapeutics

Brief Summary

The main purpose of this study is to explore the safety and tolerability of LY3471851 in healthy Japanese and Caucasian participants. The study will also estimate how much LY3471851 gets into the blood stream and how long it takes the body to remove it. The study is expected to last about 7 weeks for each participant.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-18
• Study First Submitted QC: 2019-10-18
• Study First Posted: 2019-10-21
• Study Start: 2019-10-29
• Primary Completion: 2020-03-06
• Study Completion: 2020-03-06
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Are healthy males or females, as determined by medical history and physical examination
• Are first generation Japanese or are Caucasian
• Have a body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive, at the time of screening

Exclusion Criteria

• Are currently enrolled in a clinical study involving an investigational product (IP) or any other type of medical research judged not to be scientifically or medically compatible with this study
• Have an abnormal blood pressure and/or pulse rate as determined by the investigator
• Regularly use known drugs of abuse and/or show positive findings on drug screening
• Are immunocompromised per investigator judgment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo matching LY3471851 administered SC.
LY3471851	LY3471851	Participants received single doses of 450 microgram (μg), 900 μg or 1800 μg LY3471851 administered subcutaneously (SC).

Primary Outcome Measures

Name	Time	Method
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Baseline through Study Completion (up to week 7)	A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary Outcome Measures

Name	Time	Method
PK: Maximum Concentration (Cmax) of LY3471851	Predose on Day 1 through Day 50	PK: Cmax of LY3471851
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3471851	Predose on Day 1 through Day 50	PK: AUC of LY3471851

Trial Locations

Locations (1)

WCCT Global; 🇺🇸 Cypress, California, United States