Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-31 @ 11:16 AM
Study NCT ID:
NCT04897594
Status:
COMPLETED
Last Update Posted:
2024-06-07
First Post:
2021-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
AVIATION Study: A Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy Study of TERN-201 in Patients With Non-Cirrhotic Non-Alcoholic Steatohepatitis
Sponsor:
Terns, Inc.
Organization:
Study Overview
Official Title:
A Multi-Center, Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled, Proof of Concept, Adaptive, Phase 1b Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Orally Administered TERN-201 in Patients With Presumed Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH)
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 1b multi-center, randomized, double-blind, dose-ranging, placebo-controlled, adaptive study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) of TERN-201 in patients with non-cirrhotic NASH.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: