A Study of LY3471851 in Healthy Participants
A Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3471851 in Japanese and Caucasian Healthy Subjects
2 other identifiers
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Oct 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2019
CompletedFirst Posted
Study publicly available on registry
October 21, 2019
CompletedStudy Start
First participant enrolled
October 29, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 6, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 6, 2020
CompletedNovember 18, 2023
November 1, 2023
4 months
October 18, 2019
November 15, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Baseline through Study Completion (up to week 7)
Secondary Outcomes (2)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3471851
Predose on Day 1 through Day 50
PK: Maximum Concentration (Cmax) of LY3471851
Predose on Day 1 through Day 50
Study Arms (2)
LY3471851
EXPERIMENTALParticipants received single doses of 450 microgram (μg), 900 μg or 1800 μg LY3471851 administered subcutaneously (SC).
Placebo
PLACEBO COMPARATORPlacebo matching LY3471851 administered SC.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nektar Therapeuticslead
- Eli Lilly and Companycollaborator
Study Sites (1)
WCCT Global
Cypress, California, 90630, United States
Study Officials
- STUDY DIRECTOR
Study Director
Nektar Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2019
First Posted
October 21, 2019
Study Start
October 29, 2019
Primary Completion
March 6, 2020
Study Completion
March 6, 2020
Last Updated
November 18, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share