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

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Nektar Therapeutics

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: LY3471851
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04380324
J1P-MC-KFAA (Other Identifier)
17237
16-358-01 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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 .

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

100 participants in 2 patient groups, including a placebo group

LY3471851
Experimental group
Description:
Healthy participants in each cohort will receive single subcutaneous (SC) doses of LY3471851.
Treatment:
Drug: LY3471851
Placebo
Placebo Comparator group
Description:
Healthy participants in each cohort will receive the placebo comparator.
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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