Actively Recruiting
A Randomized, Double-blind, Placebo-controlled, Multiple-dose, Dose-escalation Phase Ib/IIa Study of IMC-003 Injection in Pulmonary Arterial Hypertension Patients on Background Therapy
Led by ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd. · Updated on 2026-05-18
120
Participants Needed
32
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating IMC-003 treatment in patients with pulmonary arterial hypertension (PAH) who are already receiving background therapy. This Phase Ib/IIa clinical trial aims to assess the safety, tolerability, pharmacokinetics, and preliminary effectiveness of IMC-003 in this patient group. The study is randomized, double-blind, and placebo-controlled to provide reliable results about the treatment's impact on PAH. Participants will receive either IMC-003 injections or placebo injections eight times, once every three weeks, while continuing their stable background therapy for PAH. This dose-escalation study compares the effects of IMC-003 with placebo to help identify the recommended dose for future studies. The treatment period lasts 24 weeks. Throughout the study, participants will undergo evaluations including hemodynamic measurements like pulmonary vascular resistance, safety monitoring, and functional assessments such as the six-minute walk distance. The primary focus is on safety and tolerability by Day 169, with secondary measures assessing changes in pulmonary vascular resistance. The entire study spans several months, with careful monitoring to understand the treatment's effects and side effects.
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...
- Age between 18 and 75 years (inclusive), all genders
- Diagnosed with WHO Group 1 pulmonary arterial hypertension confirmed by right heart catheterization
- Includes idiopathic, heritable, drug- or toxin-induced PAH; inactive connective tissue disease-associated PAH; PAH with simple congenital heart defects post-correction
- Symptomatic PAH with WHO functional class II or III
- Hemodynamic criteria: mean pulmonary arterial pressure 6525 mmHg at rest; pulmonary artery wedge pressure 65415 mmHg
- Pulmonary vascular resistance 655 Wood Units by right heart catheterization prior to first dose
- Receiving stable background PAH therapy at target doses for at least 90 days before dosing
- Six-minute walk distance between 150 and 450 meters during screening
- Female participants of childbearing potential must have negative pregnancy tests and agree to effective contraception during and 16 weeks after treatment
- Male participants must agree to use condoms during treatment and for 16 weeks after, and avoid sperm donation during this time
- Understand and comply with study procedures and provide informed consent
You will not qualify if you...
- Diagnosed with pulmonary hypertension of WHO Group 2, 3, 4, or 5
- PAH subtypes excluded: HIV-associated, portal hypertension-associated, schistosomiasis-associated, pulmonary veno-occlusive disease, pulmonary capillary hemangiomatosis, or positive acute pulmonary vasoreactivity test
- Poorly controlled hypertension: seated systolic BP >160 mmHg or diastolic BP >100 mmHg, or systolic BP <90 mmHg before first dose
- Pre-dose ECG with prolonged QTc interval or personal/family history of long QT syndrome or sudden cardiac death
- Untreated mild or worse obstructive sleep apnea
- Previous or planned heart/cardiopulmonary transplantation or expected lifespan under 12 months
- Diagnosed with COPD or clinically significant lung disease
- Evidence of interstitial lung disease by recent chest CT or pulmonary function test
- Abnormal blood counts or liver/renal function outside defined limits
- History of certain liver diseases or infections including hepatitis B/C, HIV, or syphilis not cured
- Participation in other clinical studies within 30 days or still within five half-lives of investigational drugs
- Previous treatment targeting TGF-b2 superfamily
- Known allergy or hypersensitivity to investigational drug or related proteins
- History of recent serious infections
- History or current malignancy except certain treated skin or cervical conditions
- History of chronic kidney disease or recent acute renal failure requiring dialysis
- Pregnant or breastfeeding females
- Considered unsuitable for study by investigator
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 24 weeks
Participants receive eight injections of IMC-003 or placebo, administered once every three weeks, while continuing stable background therapy for pulmonary arterial hypertension.
8 injection visits spaced every three weeks
Trial Site Locations
Total: 32 locations
1
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
Not Yet Recruiting
2
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
Not Yet Recruiting
3
The first hospital of Jilin University
Jilin City, Changchun, China
Not Yet Recruiting
4
The first hospital of Jilin University
Jilin City, Changchun, China
Not Yet Recruiting
5
Fujian Medical University Union Hospita
Fuzhou, Fujian, China
Not Yet Recruiting
6
Xiamen Hospital of T.C.M.
Xiamen, Fujian, China
Not Yet Recruiting
7
Gansu Provincial Hospital
Lanzhou, Gansu, China
Not Yet Recruiting
8
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Actively Recruiting
9
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Actively Recruiting
10
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Not Yet Recruiting
11
Fuwai Center China Cardiovascular Hospital
Zhengzhou, Henan, China
Not Yet Recruiting
12
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Not Yet Recruiting
13
Wuhan Asia Heart Hospital
Wuhan, Hubei, China
Not Yet Recruiting
14
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Not Yet Recruiting
15
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Not Yet Recruiting
16
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Not Yet Recruiting
17
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
Not Yet Recruiting
18
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Not Yet Recruiting
19
General Hospital of the Northern Theater Command
Shenyang, Liaoning, China
Not Yet Recruiting
20
Qilu Hospital of Shandong University
Jinan, Shangdong, China
Not Yet Recruiting
21
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
22
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
23
Shanghai Tongji Hospital
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
24
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Not Yet Recruiting
25
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Not Yet Recruiting
26
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Not Yet Recruiting
27
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, China
Not Yet Recruiting
28
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Not Yet Recruiting
29
Kunming Yan'an Hospital
Kunming, Yunnan, China
Not Yet Recruiting
30
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Not Yet Recruiting
31
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Not Yet Recruiting
32
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Not Yet Recruiting
Research Team
X
Xiaojun Zhou
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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