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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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04133116
Enrollment
36
Registered
2019-10-21
Start date
2019-10-29
Completion date
2020-03-06
Last updated
2023-11-18

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

Conditions

Healthy

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.

Interventions

Administered SC

DRUGPlacebo

Administered SC

Sponsors

Eli Lilly and Company
CollaboratorINDUSTRY
Nektar Therapeutics
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 64 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug AdministrationBaseline 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

MeasureTime frameDescription
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3471851Predose on Day 1 through Day 50PK: AUC of LY3471851
PK: Maximum Concentration (Cmax) of LY3471851Predose on Day 1 through Day 50PK: Cmax of LY3471851

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026