Phase Ib Dose-Ranging Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of HS235 Versus Placebo in Combination with Background Therapy in Pulmonary Arterial Hypertension

The primary objective is to evaluate the safety, pharmacokinetics, and pharmacodynamics of the activin signaling inhibitor HS235 in patients diagnosed with pulmonary arterial hypertension. This dose-ranging investigation aims to establish the tolerability and biological activity of the investigational product when administered alongside background therapy. Secondary objectives include the assessment of efficacy to determine the therapeutic potential of the intervention in this patient population.

The study involves a total of 17 patients diagnosed with pulmonary arterial hypertension. The population is comprised of both male and female participants. Based on the provided age range codes, the cohort includes individuals within specific developmental or geriatric age categories. The study population is identified as a vulnerable group.

This Phase Ib dose-ranging study utilizes a randomized, double-blind, placebo-controlled design to evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of the activin signaling inhibitor HS235 compared to a placebo in patients with pulmonary arterial hypertension. Participants will receive the study intervention in addition to their background therapy. The clinical investigation includes a screening visit to assess eligibility, followed by scheduled follow-up visits to monitor clinical progress and safety parameters. The protocol concludes with an end-of-study visit. The total duration of the trial is expected to extend from January 2026 to January 2028. Clinical circumstances or specific medical criteria may lead to the early termination of participation in the study.

Efficacy in the management of pulmonary arterial hypertension will be evaluated according to the established clinical protocol. The assessment parameters and methodologies for determining therapeutic response are not specified in the current documentation.