drugset / Trial / NCT05743010
A Phase 1b Study to Evaluate APL-1401 in Patients With Moderately to Severely Active Ulcerative Colitis
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a randomized, double-blind, placebo-controlled, phase 1b study designed to evaluate safety, tolerability, PK, and preliminary efficacy of APL-1401 in patients with moderately to severely active UC. This study comprises 3 periods including screening period (D-28\~D-1), treatment period (D1-D28), and safety follow-up period(D29-D58).
Timeline
- Start
- 2023-01-26
- Primary completion
- 2025-03
- Completion
- 2025-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nepicastat | Small molecule | 120 mg | Oral |
| Subject | Nepicastat | Small molecule | 160 mg | Oral |
| Subject | Nepicastat | Small molecule | 200 mg | Oral |