A Study of HS235 for Treatment of Pulmonary Arterial Hypertension (PAH) in Adults

ConditionPulmonary Arterial Hypertension

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18+

Sponsor35Pharma Inc

About this trial

Phase 1b/2 Study of HS235 Assessing the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of the Activin Signaling Inhibitor HS235 Added to Background Treatment in Adults with Pulmonary Arterial Hypertension (PAH)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male and female participants, 18 years of age and older.

Body Mass Index (BMI) 18.5 and 40 kg/m2 and body weight at or below 120 kg.

A minimum PVR of ≥ 5 Wood units (WU) or ≥ 400 dyn·sec·cm-5 and,

A pulmonary artery wedge pressure (PAWP) of ≤ 15 mm Hg.

Disqualifiers

PH WHO Groups 2, 3, 4 or 5.

Hospitalization for any worsening medical condition or major surgery within 4 weeks prior to screening.

Any symptomatic coronary disease events.

History of heart transplant or on heart transplant list.

Trial design

Design model

Sequential

Treatments tested in this trial

HS235
Biological/Vaccine
Subcutaneous Injection
Placebo
Other intervention
Subcutaneous Injection

Treatment groups

90 Participants

are divided into 2 treatment groups

Group A: HS235Experimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Incidence and Number of Adverse Events (AEs)

An AE is any untoward medical occurrence in a participants or clinical trial participants administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The incidence and number of participants who experience an AE will be reported.

Time frame

up to 29 weeks