Phase 1b/2, Multicenter, Double-Blind, Placebo-Controlled, Multiple Dose Study Assessing the Pharmacokinetics, Safety, Pharmacodynamics, and Efficacy of HS235 in Obese Participants With Pulmonary Hypertension and HFpEF
35Pharma Inc
Summary
Study of HS235 in Obese Participants with Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction
Description
A Phase 1b/2, Multicenter, Double-Blind, Placebo-Controlled, Multiple Dose Study Assessing the Pharmacokinetics, Safety, Pharmacodynamics, and Efficacy of HS235 in Obese Participants with Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Participants are eligible to be included in the study only if they meet at least all the following criteria: 1. Male or female, ≥ 18 years of age. 2. \[Sub-population A only - using a remote PAP sensor\]- Ambulatory PAP monitoring (e.g., CardioMEMS™ HF System or Cordella™ HF System) implanted in the course of standard of care at least 90 days before Screening. Hemodynamic evidence of PH with: 1. mPAP ≥ 25 mm Hg, as measured in supine position by the averaged 7-day values (weekly average) 2 weeks and 1 week before Randomization AND, 2. dPAP ≥ 15 mm Hg, as measure…
Interventions
- BiologicalHS235
Subcutaneous Injection
- OtherPlacebo
Subcutaneous Injection
Location
- Investigational Site-101Greenville, South Carolina