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OpenTrials
Completed

NCT Number: NCT04380324

A Study of NKTR-358 (LY3471851) in Healthy Participants

The main purpose of this study is to evaluate the safety and tolerability of a study drug known as LY3471851 in healthy participants. The study will last about 50 days for each participant.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRA Health Sciences

Lenexa, Kansas, 66219, United States

About this study

LY3471851 is a potential first-in-class therapeutic that may address an underlying immune system imbalance in people with many autoimmune conditions. It targets the interleukin (IL-2) receptor complex in the body in order to stimulate proliferation of inhibitory immune cells known as regulatory T cells. By activating these cells, LY3471851 may act to bring the immune system back into balance.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Overtly healthy males and females, as determined by medical history and physical examination
  • Have a body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m²)

Exclusion criteria

  • Previous or current autoimmune disease/disorder
  • Current active bacterial, viral, or fungal infection
  • Administration of an inactivated vaccine within two weeks of study drug administration or live attenuated vaccine within 90 days of dosing .

Treatment and study plan

LY3471851

Drug

LY3471851 drug product is a sterile liquid for SC injection that may be diluted with sterile 0.9% sodium chloride solution for injection (USP) prior to administration.

Other names: NKTR-358

Placebo

Drug

The placebo dosing solution is 0.9% sodium chloride for injection (USP).

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 up to Day 50

    Number of Participants with One or More SAEs Considered by the Investigator to be Related to Study Drug Administration

Secondary outcomes

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3471851

    Time frame: Predose on Day 1 through Day 50

    PK: Cmax of LY3471851

  2. PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of LY3471851

    Time frame: Predose on Day 1 through Day 50

    PK: (AUC[0-inf]) of LY3471851

  3. Pharmacodynamics (PD): Mean Change from Baseline in Regulatory T cells (Tregs)

    Time frame: Predose on Day 1 through Day 50

    PD: Mean change from baseline in Tregs

  4. PD: Change from Baseline in Treg Activation Markers

    Time frame: Predose on Day 1 through Day 50

    PD: Treg activation markers include: Cytokine levels, conventional CD4+ and CD8+ Tcells, and natural killer (NK) cells

Sponsors and collaborators

Lead sponsor

Nektar Therapeutics

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

A Phase 1, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous Dose of NKTR-358 in Healthy Volunteers

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 8, 2020
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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