RecruitingPulmonary Arterial Hypertension

An Adaptive Program of IKT-001 in Pulmonary Arterial Hypertension (PAH)

Eligible age

18–75 yrs

Accepts

All genders

Locations

2 states

Healthy volunteers

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About this study

This is an adaptive, 2-part, randomized, multicenter, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of IKT-001 in adult participants with WHO Group 1 PAH.

Sponsor: Inhibikase Therapeutics

You may qualify if…

✓ Documented diagnosis of WHO PAH Group 1 in any of the following subtypes:
✓ Idiopathic PAH
✓ Heritable PAH
✓ Drug/toxin-induced PAH
✓ PAH associated with connective tissue disease (CTD)
✓ PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair
✓ Men and women 18 and 75 years of age (inclusive)
✓ Must have a body mass index (BMI) of ≥18.5 kg/m\^2 and ≤35.0 kg/m\^2 at screening.

You may not qualify if…

✕ Diagnosis of PAH WHO Groups 2, 3, 4, or 5.
✕ Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH, PAH associated with portal hypertension, schistosomiasis-associated PAH, and pulmonary veno-occlusive disease.
✕ Any of the following blood pressure-related values or abnormalities: Uncontrolled systemic hypertension as evidenced by sitting systolic BP \>160 mmHg or sitting diastolic BP \>100 mmHg at screening, Baseline systolic BP \<90 mmHg at screening, Syncope within 3 months prior to screening
✕ History of restrictive, constrictive, or congestive cardiomyopathy.
✕ ECG with Fridericia's corrected QT interval (QTcF) ≥ 450 msec in males or ≥ 470 msec in females at screening or ≥500 msec in the presence of a right bundle branch block.
✕ Personal or family history of long QT syndrome or sudden cardiac death.
✕ Presence of a CardioMEMS device or any other implanted hemodynamic monitoring device.
✕ Forced vital capacity (FVC) \<70 percent on pulmonary function test (PFT) performed no more than 6 months prior to screening; or if FVC is 60 percent to 69 percent, must have a chest computed tomography scan within 12 months with no more than mild interstitial lung disease.

Where it's recruiting

Kentucky

Louisville

Massachusetts

Boston

Source: ClinicalTrials.gov · NCT07365332 · last updated 2026-05-12