A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Finding Trial to Evaluate the Efficacy and Safety of Orally Administered NS-863 in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

NS Pharma, Inc.

Summary

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Dose Finding Trial to Evaluate the Efficacy and Safety of Orally Administered NS-863 in Participants with Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD)

Eligibility

Age range: 18–80 years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: Participants must meet all of the following criteria to be included in the trial: * Ability to provide written informed consent prior to participation in the trial, which includes the ability to comply with the requirements and restrictions listed in the informed consent form (ICF). Participants must be able to read, comprehend, and write at a level sufficient to complete trial-related materials * Adult male or female participants 18 (19 years in South Korea) to 80 years of age at the time the ICF is signed * A confirmed diagnosis of the following WHO Group 3 PH based on…

Interventions

Drug
NS-863 Low Dose
NS-863 is an orally administered drug.
Drug
NS-863 High Dose
NS-863 is an orally administered drug.
Other
Placebo
An orally administered NS-863 matching placebo.

Locations (4)

AnMed Clinical Research
Anderson, South Carolina
StatCare Pulmonary Consultants, PLLC
Knoxville, Tennessee
National Hospital O Okayama MC
Okayama, Okayama-ken
Hospital of the University of Occupational and Environmental Health
Kitakyushu

Compensation

Estimated

~$75 – $2,800

Arctuva estimate

Actual pay is set by the research site.

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Details

NCT ID: NCT07441278
Type: Drug
Last updated: 10/27/2026