First-in-Human Study of SRT-015 in Healthy Subjects.

PHASE1CompletedINTERVENTIONAL
Enrollment

81

Participants

Timeline

Start Date

May 3, 2021

Primary Completion Date

February 28, 2022

Study Completion Date

February 28, 2022

Conditions
Nonalcoholic Steatohepatitis
Interventions
DRUG

SRT-015

Each study part (A,B and C) will be completed sequentially, but with partial overlapping. The first cohort of Part B (Cohort B1) may be initiated after safety, tolerability and available PK data are assessed and deemed suitable to continue for a single dose on Part A that is equal to or greater than the total exposure of cohort B1. Part C (Cohort C1 \& C2) may be initiated after safety, tolerability and PK data are assessed and deemed suitable to continue for a single dose in part A that is at least double the specified dose from part C.

OTHER

Matching Placebo for SRT-015

Matching Placebo

Trial Locations (1)

3004

Nucleus Network Pty Ltd, Victor Harbor

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Syneos Health

OTHER