Trials / Completed
CompletedNCT04715529
Phase 1 Study to Evaluate Safety and Pharmacokinetics of FZJ-003 in Healthy Volunteers
A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose-escalation and Food Effect Study to Assess the Safety, Tolerance, and Pharmacokinetics of FZJ-003 In Healthy Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 62 (actual)
- Sponsor
- Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
A randomized, double-blinding, dose-escalated phase 1 trial to evaluate the tolerance and fasting/postprandial pharmacokinetics of FZJ-003, an oral Janus kinase1 (JAK1) inhibitor.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FZJ-003 | Subjects will receive FZJ-003 oral capsules in a dose escalation format. |
| DRUG | Placebo | Subjects will receive placebo oral capsules (matching FZJ-003) in a dose escalation format . |
Timeline
- Start date
- 2021-01-27
- Primary completion
- 2022-07-13
- Completion
- 2022-07-13
- First posted
- 2021-01-20
- Last updated
- 2025-03-12
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04715529. Inclusion in this directory is not an endorsement.