Trials / Completed
CompletedNCT05119972
Tolerability, Pharmacokinetics and Efficacy of ZSP1603 in Patients With Idiopathic Pulmonary Fibrosis （IPF）
A Multi-center, Phase Ib/IIa Clinical Trial to Evaluate the Tolerability, PK and Efficacy of ZSP1603 in Patients With Idiopathic Pulmonary Fibrosis
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Guangdong Raynovent Biotech Co., Ltd · Industry
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
Summary
This study was divided into two parts. The first part was a dose escalation study: a open label dose escalation design was used to evaluate the safety, tolerance and pharmacokinetic characteristics of ZSP1603 in IPF patients. The second part was a randomized double-blind placebo-controlled design was used to preliminatively investigate the efficacy and safety of ZSP1603 in the treatment of IPF at the target dose.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ZSP1603 | ZSP1603 administered orally |
| DRUG | Placebo | Placebo administered orally |
Timeline
- Start date
- 2021-10-21
- Primary completion
- 2023-12-21
- Completion
- 2023-12-21
- First posted
- 2021-11-15
- Last updated
- 2025-03-19
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05119972. Inclusion in this directory is not an endorsement.