drugset / Trial / NCT06643143

A Phase 2 Study of IkT-001Pro in Pulmonary Arterial Hypertension (PAH)

NCT06643143

Phase 2 Withdrawn Inhibikase Therapeutics
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

EvaluationDrugModalityDoseRoute
Subject IKT-001PRO FREE BASE Small molecule 300 mg
Subject IKT-001PRO FREE BASE Small molecule 500 mg