NCT04380324

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Nektar Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	LY3471851	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.
DRUG	Placebo	The placebo dosing solution is 0.9% sodium chloride for injection (USP).

Timeline

• Start date: 2017-03-19
• Primary completion: 2019-01-20
• Completion: 2019-01-20
• First posted: 2020-05-08
• Last updated: 2023-11-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study