Trials / Completed
CompletedNCT04140123
Tolerability, Efficacy, and PK of ZSP1601 in Patients With Non-Alcoholic Steatohepatitis (NASH)
A Multi-center, Randomized, Double-blind, Dose-increasing, Placebo-controlled，Multi-dose, 28-day Continuous Administration Phase Ib/IIa Clinical Trial to Evaluate the Tolerability, Efficacy, and PK of ZSP1601 in Patients With Nonalcoholic Steatohepatitis
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 37 (actual)
- Sponsor
- Guangdong Raynovent Biotech Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
Double-blind, randomized, placebo-controlled study to explore the safety, tolerability PK characteristics and early efficacy of ZSP1601 tablets in patients with non-alcoholic steatohepatitis (NASH).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ZSP1601 | ZSP1601 tablets be taken orally for 28 days. |
| DRUG | ZSP1601 Placebo | Subjects will receive matching placebo of ZSP1601 |
Timeline
- Start date
- 2020-06-23
- Primary completion
- 2021-08-03
- Completion
- 2021-08-03
- First posted
- 2019-10-25
- Last updated
- 2021-10-11
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04140123. Inclusion in this directory is not an endorsement.