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

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04380324
• Other study ID #: 17237
• Secondary ID: J1P-MC-KFAA16-35
• Status: Completed
• Phase: Phase 1
• Start date: March 19, 2017
• Est. completion date: January 20, 2019

Study information

• Verified date: November 2023
• Source: Nektar Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 20, 2019
• Est. primary completion date: January 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
United States	PRA Health Sciences	Lenexa	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Nektar Therapeutics	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Number of Participants with One or More SAEs Considered by the Investigator to be Related to Study Drug Administration	Baseline up to Day 50
Secondary	Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3471851	PK: Cmax of LY3471851	Predose on Day 1 through Day 50
Secondary	PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of LY3471851	PK: (AUC[0-inf]) of LY3471851	Predose on Day 1 through Day 50
Secondary	Pharmacodynamics (PD): Mean Change from Baseline in Regulatory T cells (Tregs)	PD: Mean change from baseline in Tregs	Predose on Day 1 through Day 50
Secondary	PD: Change from Baseline in Treg Activation Markers	PD: Treg activation markers include: Cytokine levels, conventional CD4+ and CD8+ Tcells, and natural killer (NK) cells	Predose on Day 1 through Day 50