Status:
COMPLETED
First-in-Human Study of SRT-015 in Healthy Subjects.
Lead Sponsor:
Syneos Health
Conditions:
Nonalcoholic Steatohepatitis
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
This is phase 1 first-in-human trial evaluating SRT-015 to assess safety, tolerability and pharmacokinetics. This study will be conducted in 3 parts - SAD, MAD and Food Effect with target of 96 health...
Detailed Description
The study will be divided into three parts: Part A: SAD- Randomized, double-blind, placebo-controlled single oral escalating dose of SRT-015 or placebo in five cohorts (A1-A5). Each cohort will inclu...
Eligibility Criteria
Inclusion
- Key
- Males or females aged 18 to 45 years of age with a BMI \>18.0 and \<32.0 kg/m2 and body weight greater than or equal to 50kg for males and greater than or equal to 45 kg for females.
- Casual smoker (defined by the consumption of no more than 5 cigarettes per week, and willing to abstain from the consumption of cigarettes and related products for the study duration) or non smoker.
- Agree to use appropriate contraception.
- Key
Exclusion
- Any clinically significant abnormality at physical examination, clinically significant abnormal laboratory test results (liver function tests must be strictly within normal ranges) or positive test for HIV, hepatitis B, or hepatitis C found during medical screening.
- Positive urine drug screen or alcohol breath test at screening and check-in (Day -1).
- Positive pregnancy test, or breast feeding.
- Clinically significant 12-lead ECG abnormalities.
- Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
Key Trial Info
Start Date :
May 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2022
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT04887038
Start Date
May 3 2021
End Date
February 28 2022
Last Update
April 20 2022
Active Locations (1)
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1
Nucleus Network Pty Ltd
Victor Harbor, Melbourne, Australia, 3004