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
3 other identifiers
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Mar 2017
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2019
CompletedFirst Submitted
Initial submission to the registry
May 6, 2020
CompletedFirst Posted
Study publicly available on registry
May 8, 2020
CompletedNovember 18, 2023
November 1, 2023
1.8 years
May 6, 2020
November 15, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Pharmacokinetics (PK): Maximum Concentration (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
Predose on Day 1 through Day 50
Pharmacodynamics (PD): Mean Change from Baseline in Regulatory T cells (Tregs)
Predose on Day 1 through Day 50
PD: Change from Baseline in Treg Activation Markers
Predose on Day 1 through Day 50
Study Arms (2)
LY3471851
EXPERIMENTALHealthy participants in each cohort will receive single subcutaneous (SC) doses of LY3471851.
Placebo
PLACEBO COMPARATORHealthy participants in each cohort will receive the placebo comparator.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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 .
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nektar Therapeuticslead
- Eli Lilly and Companycollaborator
Study Sites (1)
PRA Health Sciences
Lenexa, Kansas, 66219, United States
Study Officials
- STUDY DIRECTOR
Study Director
Nektar Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2020
First Posted
May 8, 2020
Study Start
March 19, 2017
Primary Completion
January 20, 2019
Study Completion
January 20, 2019
Last Updated
November 18, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share