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OpenTrials
Completed

NCT Number: NCT04133116

A Study of LY3471851 in Healthy Participants

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.

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Key information

Conditions

Healthy

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

WCCT Global

Cypress, California, 90630, United States

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

LY3471851

Drug

Administered SC

Other names: NKTR-358

Placebo

Drug

Administered SC

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

    Time frame: 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 outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3471851

    Time frame: Predose on Day 1 through Day 50

    PK: AUC of LY3471851

  2. PK: Maximum Concentration (Cmax) of LY3471851

    Time frame: Predose on Day 1 through Day 50

    PK: Cmax of LY3471851

Sponsors and collaborators

Lead sponsor

Nektar Therapeutics

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

A Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3471851 in Japanese and Caucasian Healthy Subjects

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 21, 2019
Registry last updated
Nov 18, 2023

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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