drugset / Trial / NCT06643143
A Phase 2 Study of IkT-001Pro in Pulmonary Arterial Hypertension (PAH)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a randomized, double-blind, multi-center, placebo-controlled dose-ranging clinical trial of two IkT-001Pro doses in patients with PAH designed to assess safety, tolerability and efficacy. It will enroll approximately 150 participants at up to 50 sites globally. The study consists of two parts, a 26 week placebo controlled treatment period (Part A) followed by a 36 month extension period (Part B).
Timeline
- Start
- 2025-06-30
- Primary completion
- 2027-06-30
- Completion
- 2027-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | IKT-001PRO FREE BASE | Small molecule | 300 mg | — |
| Subject | IKT-001PRO FREE BASE | Small molecule | 500 mg | — |