NCT06493461TerminatedPhase 1
Phase 1b, Multicenter, Open-Label, Multiple Ascending Dose Study Assessing the Pharmacokinetics, Safety, Pharmacodynamics, and Efficacy of HS135 Added to Background Pulmonary Arterial Hypertension (PAH) Therapy
35Pharma Inc2 sites in 2 countries5 target enrollmentStarted: October 23, 2024Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Enrollment
- 5
- Locations
- 2
- Primary Endpoint
- Adverse Events (AEs)
Study Overview
Brief Summary
A Study of HS135 for the Treatment of Pulmonary Arterial Hypertension in Adults
Detailed Description
Phase 1b, Multicenter, Open-Label, Multiple Ascending Dose Study Assessing the Pharmacokinetics, Safety, Pharmacodynamics, and Efficacy of HS135 Added to Background Pulmonary Arterial Hypertension (PAH) Therapy
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male and female patients, 18 years of age and older.
- •Body Mass Index (BMI) 18.5 and 40 kg/m2 and body weight at or below 120 kg
- •Documented diagnostic RHC at any time prior to screening.
- •Diagnosis of WHO PAH Group
- •Symptomatic PAH classified as WHO FC II to IV.
- •Baseline RHC performed during the Screening Period documenting a minimum PVR of ≥ 5 Wood units (WU) or ≥ 400 dyn ・ sec ・ cm-5 and a pulmonary artery wedge pressure (PAWP) of ≤ 15 mmHg.
- •On stable doses of at least 2 background PAH therapies.
Exclusion Criteria
- •Left ventricular ejection fraction < 50% at screening.
- •Any symptomatic coronary disease events within 6 months of the screening visit.
- •Uncontrolled systemic hypertension.
- •History of restrictive, constrictive or congestive cardiomyopathy.
- •History of atrial septostomy.
- •Patients who have an abnormality in the Echocardiogram or in the 12-lead ECG that, in the opinion of the Investigator, increases the risk of participating in the study.
- •Pulmonary function test (PFT) values of forced vital capacity (FVC) and or FEV1 < 60% predicted at the screening visit or within 6 months prior to the screening visit.
Arms & Interventions
HS135
Experimental
Subcutaneous Injection
Intervention: HS135 (Biological)
Outcomes
Primary Outcomes
Adverse Events (AEs)
Time Frame: Up to 24 weeks
Change from Baseline in Physical Examination
Time Frame: Up to 24 weeks
Physical Examination will include the assessment of body systems.
Change from Baseline in Clinical Laboratory Parameters
Time Frame: Up to 24 weeks
Change from Baseline in Blood Pressure
Time Frame: Up to 24 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Terminated
Phase 3
Iloprost Power Disc-15 in Pulmonary Arterial HypertensionPulmonary Arterial HypertensionNCT00723554Actelion63
Terminated
Phase 1
Study of HS135 in Obese Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection FractionPulmonary HypertensionNCT0658115935Pharma Inc4
Completed
Phase 2
A Study of Sotatercept for the Treatment of Pulmonary Arterial HypertensionPulmonary Arterial HypertensionNCT03738150Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA21
Unknown
Phase 3
SPHERIC-1. Sildenafil and Pulmonary HypERtension In COPDCOPDPulmonary HypertensionNCT01441934Italian Association of Hospital Pneumologists32
Not yet recruiting
Not Applicable
Assessment of patients with pulmonary hypertension using cardiopulmonary exercise testingTo investigate cardiopulmonary responses to exercise in Thai patients with idiopathic pulmonary arterial hypertension (IPAH),systemic sclerosis-associated pulmonary arterial hypertension (SSc-associaPAH,CPETTCTR20171229001Research Affair Faculty of Medicine Khon Kaen University20