| Trial ID: | L0386 |
| Source ID: | NCT04897594
|
| Associated Drug: |
TERN-201
|
| 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 Presu
|
| Acronym: |
--
|
| Status: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
NASH - Nonalcoholic Steatohepatitis
|
| Interventions: |
Drug: TERN-201;Other: Placebo
|
| Outcome Measures: |
Subject incidence of adverse events for TERN-201 versus placeboPlasma and urine concentration of TERN-201- AUC;Plasma and urine concentration of TERN-201- Cmax;Plasma and urine concentration of TERN-201- Tmax;Plasma and urine concentration of TERN-201- T1/2;Percent Change from baseline in plasma VAP-1/SSAO activity
|
| Sponsor/Collaborators: |
Terns, Inc.
|
| Gender: |
All
|
| Age: |
18 Years75 Years
|
| Phases: |
Phase 1
|
| Enrollment: |
60
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
|
| Start Date: |
18/05/2021
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
28 February 2022
|
| Locations: |
United States
|
| URL: |
https://clinicaltrials.gov/show/NCT04897594
|
