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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: LY3471851; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • PRA Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY3471851; Healthy participants in each cohort will receive single subcutaneous (SC) doses of LY3471851.	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.; Other Names: NKTR-358
Placebo Comparator: Placebo; Healthy participants in each cohort will receive the placebo comparator.	Drug: Placebo; The placebo dosing solution is 0.9% sodium chloride for injection (USP).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3471851	PK: Cmax of LY3471851	Predose on Day 1 through Day 50
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
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
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

Collaborators and Investigators

• Sponsor: Nektar Therapeutics
• Collaborators: Eli Lilly and Company
• Investigators: Study Director: Study Director, Nektar Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2017
• Primary Completion (Actual): January 20, 2019
• Study Completion (Actual): January 20, 2019

Study Registration Dates

• First Submitted: May 6, 2020
• First Submitted That Met QC Criteria: May 6, 2020
• First Posted (Actual): May 8, 2020

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 17237 (City of Hope Medical Center); J1P-MC-KFAA (Other Identifier: Eli Lilly and Company); 16-358-01 (Other Identifier: Nektar Therapeutics)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No