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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-19

Study Completion Date

2019-01-20

Brief Summary

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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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Detailed Description

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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

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY3471851

Healthy participants in each cohort will receive single subcutaneous (SC) doses of LY3471851.

Group Type EXPERIMENTAL

LY3471851

Intervention Type 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.

Placebo

Healthy participants in each cohort will receive the placebo comparator.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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NKTR-358

Eligibility Criteria

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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 .

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes