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

Sponsor
35Pharma Inc
Study ID
NCT07143448
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Pulmonary Arterial Hypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HS235 — BIOLOGICAL
    Subcutaneous Injection
  • Placebo — OTHER
    Subcutaneous Injection

Study Details

Phase 1b 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)

Key Dates

First listed
Aug 27, 2025
Start date
Oct 31, 2025
Status verified
Aug 2025
Primary completion
Apr 30, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: HS235
    HS235 Subcutaneous Injection
  • Placebo Comparator: Placebo
    Subcutaneous Injection

Primary Outcome Measure

Incidence and Number of Adverse Events (AEs) [ Time Frame: up to 24 weeks ]

Central Contacts

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