Clinical trial

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

Name

17237

Description

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 arms

Trial start

2017-03-19

Estimated PCD

2019-01-20

Trial end

2019-01-20

Status

Completed

Phase

Early phase I

Treatment

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.

Arms:

LY3471851

Other names:

NKTR-358

Placebo

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

Arms:

Placebo

Size

100

Primary endpoint

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Baseline up to Day 50

Eligibility criteria

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 .

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ACTUAL'}}

Updated at

2023-11-18

1 organization

2 products

1 indication

Organization

Product

Indication

Product