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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: LY3471851

• Registration Number: NCT04380324
• Lead Sponsor: Nektar Therapeutics

Brief 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.

Study Timeline

• Study Start: 2017-03-19
• Primary Completion: 2019-01-20
• Study Completion: 2019-01-20
• Study First Submitted: 2020-05-06
• Study First Submitted QC: 2020-05-06
• Study First Posted: 2020-05-08
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Healthy participants in each cohort will receive the placebo comparator.
LY3471851	LY3471851	Healthy participants in each cohort will receive single subcutaneous (SC) doses of LY3471851.

Primary Outcome Measures

Name	Time	Method
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	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 Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3471851	Predose on Day 1 through Day 50	PK: Cmax of LY3471851
Pharmacodynamics (PD): Mean Change from Baseline in Regulatory T cells (Tregs)	Predose on Day 1 through Day 50	PD: Mean change from baseline in Tregs
PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of LY3471851	Predose on Day 1 through Day 50	PK: (AUC\[0-inf\]) of LY3471851
PD: Change from Baseline in Treg Activation Markers	Predose on Day 1 through Day 50	PD: Treg activation markers include: Cytokine levels, conventional CD4+ and CD8+ Tcells, and natural killer (NK) cells

Trial Locations

Locations (1)

PRA Health Sciences; 🇺🇸 Lenexa, Kansas, United States