Actively Recruiting
Phase IbIIa Study of IMC-003 Injection Added to Background Therapy for Pulmonary Arterial Hypertension in Adults
Led by ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd. · Updated on 2026-07-22
120
Participants Needed
29
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase IbIIa clinical trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of IMC-003 injection in adults with pulmonary arterial hypertension PAH who are already receiving background therapy. The trial focuses on patients with WHO Group 1 PAH, including several subtypes such as idiopathic, heritable, and drug-induced PAH. Participants must have symptomatic PAH with specific functional classifications and hemodynamic criteria confirmed by right heart catheterization. Participants will be randomly assigned to receive either IMC-003 or a placebo, injected eight times every three weeks while continuing their stable background PAH treatment. Background therapy includes approved drugs such as endothelin receptor antagonists, PDE-5 inhibitors, sGC stimulators, and prostacyclin analogs. The study is double-blinded and parallel in design, and treatment will last for 24 weeks in both phases of the trial. During the study, participants will undergo various assessments including heart MRI, 6-minute walk distance tests, and blood tests measuring NT-proBNP and other hemodynamic parameters. Researchers will monitor safety, disease progression, and treatment effects throughout the 24-week treatment period. The study also includes ongoing evaluation of symptoms, functional classification, and laboratory markers to understand the impact of IMC-003 in this patient population.
CONDITIONS
Brief Title
A Phase Ⅰb/Ⅱa Clinical Study of IMC-003 Injection for the Treatment of Pulmonary Arterial Hypertension Receiving Background Therapy.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 18-75 years old, any gender
- Diagnosed with WHO Group 1 pulmonary arterial hypertension by right heart catheterization
- Includes idiopathic, heritable, drug- or toxin-induced, inactive connective tissue disease-associated PAH, and congenital heart disease-related PAH at least 1 year post-repair
- Symptomatic pulmonary arterial hypertension with WHO functional class II or III
- Hemodynamic criteria: mean pulmonary arterial pressure ≥25 mmHg; pulmonary arterial wedge pressure ≤15 mmHg
- Pulmonary vascular resistance ≥5 Wood Units measured within 10 days before dosing
- Receiving stable doses of approved background PAH therapy for at least 90 days
- Mean of two 6-minute walk distance tests between 150 and 450 meters with a maximum difference of 15%
- Female participants of childbearing potential must have negative pregnancy tests and agree to contraception during and after treatment
- Male participants must agree to use condoms during and after treatment
- Ability to understand and follow study procedures and provide informed consent
You will not qualify if you...
- Diagnosed with WHO Group 2, 3, 4, or 5 pulmonary hypertension
- PAH subtypes excluded: HIV-associated, portal hypertension-associated, schistosomiasis-associated, pulmonary veno-occlusive disease, or positive acute pulmonary vasoreactivity test
- Left ventricular ejection fraction below 45% or significant heart disease
- Poorly controlled hypertension or low blood pressure before dosing
- Prolonged QT interval or history of sudden cardiac death
- Recent symptomatic coronary artery disease or cerebrovascular accident
- Use of intravenous positive inotropic agents within 30 days before screening
- History of thrombosis or bleeding within specified recent periods
- Untreated obstructive sleep apnea
- Prior or planned heart or lung transplant or expected lifespan under 12 months
- Chronic obstructive pulmonary disease or significant lung diseases
- Evidence of interstitial lung disease from recent chest CT or lung function tests
- Abnormal blood counts or liver and kidney function outside specified limits
- History of liver disease, positive viral hepatitis, HIV, or syphilis infections
- Current participation in other clinical studies or recent investigational drug use
- Previous treatment targeting TGF-beta superfamily or known allergies to study drugs
- Recent cardiopulmonary rehabilitation changes or planned initiation
- Recent severe infections or major surgery not fully recovered
- Recent corticosteroid therapy above specified doses or unstable immunosuppressive therapy
- History of malignancy except certain treated skin or cervical conditions
- Autoimmune disease except related to PAH etiology
- History of chronic kidney disease or recent acute kidney injury
- Pregnant or breastfeeding women
- Deemed unsuitable by investigator for any reason
Research Team
X
Xiaojun Zhou
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