Pulmonary Arterial Hypertension PAHPhase 1/2NCT07593027
A Phase Ⅰb/Ⅱa Clinical Study of IMC-003 Injection for the Treatment of Pulmonary Arterial Hypertension Receiving Background Therapy.
A Phase 1/2 study testing IMC-003 and PAH background therapy in people with Pulmonary Arterial Hypertension PAH, run by ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd. at 29 sites in China.
Trial summary
This is a Phase Ib/IIa clinical study of IMC-003 treatment in pulmonary arterial hypertension (PAH) patients receiving background therapy Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Arterial Hypertension PAH
- What is being tested?
- IMC-003 and PAH background therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 29 sitesChina
- Study dates
- 30 Apr 2026to 30 Nov 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants aged 18-75 years old (inclusive), any gender;
- Patients diagnosed with WHO Group 1 pulmonary arterial hypertension (PAH) via right heart catheterization (RHC) before dosing (see Appendix 1), including the following subtypes:
- Idiopathic PAH;
- Heritable PAH;
- Drug- or toxin-induced PAH;
- Inactive, connective tissue disease-associated PAH;
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- Simple congenital heart disease with left-to-right shunt-related PAH, at least 1 year post-repair surgery;
- Symptomatic pulmonary arterial hypertension, WHO functional class II or III ;
- Must also meet the following hemodynamic criteria:
- Mean pulmonary arterial pressure (mPAP) at rest ≥25 mmHg;
- Pulmonary arterial wedge pressure (PAWP) ≤15 mmHg;
- Pulmonary vascular resistance (PVR) measured by RHC within 10 days before initial dosing ≥5 Wood Units (400 dyn·sec·cm-5), prior RHC results before screening are acceptable if they meet study requirements;
- Receiving stable doses of background PAH therapy (i.e., for at least 90 days before first dosing, individualized target doses for each therapy reached and stable); for subcutaneous prostacyclin users, a 10% variation around the optimal dose is allowed following medical practice, detailed as follows:
- Background PAH therapy refers to approved PAH-specific drugs, including ERA and/or PDE-5i or sGC stimulators and/or prostacyclin analogs or receptor agonists (subcutaneous). Note: PAH background therapy drugs should meet the following doses: Macitentan 10 mg qd, Ambrisentan 10 mg qd; Sildenafil ≥20 mg tid, Tadalafil 20-40 mg qd; Riociguat 2 mg or 2.5 mg tid; Selexipag 0.8-1.6 mg bid; Subcutaneous treprostinil ≥20 ng/kg/min. Note: Drugs used for acute pulmonary vasoreactivity testing are not considered background therapy.
- During screening and within 10 days before first dosing, the mean of two 6-minute walk distance (6MWD) tests should be ≥150m and ≤450m, with a maximum difference of 15% (based on the higher value); the two tests should be at least 4 hours apart and no longer than 1 week apart (if the difference exceeds 15%, repeat once within 4 hours to 1 week).
- Female participants of childbearing potential must have a negative serum pregnancy test before dosing, agree to regular urine or serum pregnancy tests during treatment (any one), use highly effective contraception before dosing, during treatment (including dosing interruption) and for 16 weeks (112 days) after the last dose, and avoid blood or egg donation for 16 weeks (112 days) after the last dose.
- Male participants agree to use condoms, defined as using latex condoms or non-latex condoms made from non-natural (animal) membranes (e.g., polyurethane) during sexual activity with pregnant women or women of childbearing potential during the dosing period (including any interruption) and for 16 weeks (112 days) after the last dose, even if they have successfully undergone a vasectomy, and to avoid donating sperm during this time;
- Participants understand and follow the study procedures, voluntarily participate, and sign the informed consent form.
Who cannot join
- 1) Diagnosed with WHO Group 2, 3, 4, or 5 pulmonary hypertension. 2) Diagnosed with the following PAH subtypes in WHO Group 1:
- HIV-associated PAH
- Portal hypertension-associated PAH
- Schistosomiasis-associated PAH
- PAH associated with pulmonary veno-occlusive disease or pulmonary capillary hemangiomatosis
- PAH patients with known positive acute pulmonary vasoreactivity test 3) History of echocardiogram within 6 months before screening showing left ventricular ejection fraction <45%, or pre-dose echocardiogram showing left ventricular ejection fraction <45%, or as assessed by the investigator, acute decompensated heart failure occurring within 30 days before screening, or evidence or history of clinically significant heart disease (including but not limited to: significant (≥2+) mitral or aortic valve regurgitation, restrictive or congestive cardiomyopathy, or pericardial constriction).
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- 4) Poorly controlled hypertension at rest during the screening period: seated systolic BP >160 mmHg or seated diastolic BP >100 mmHg, or pre-dose systolic BP <90 mmHg on Day 1.
- 5) Pre-dose ECG Fridericia corrected QT interval (QTcF) ≥470 ms for men, ≥480 ms for women, or personal/family history of long QT syndrome (LQTS) or sudden cardiac death.
- 6) Any symptomatic coronary artery disease event (previous myocardial infarction, PCI, CABG, or angina), or history of cerebrovascular accident within 3 months before screening. Note: if coronary angiography shows no obstruction (lumen stenosis ≤50%), angina may not be an exclusion.
- 7) Use of IV positive inotropic agents (such as dobutamine, dopamine, norepinephrine, vasopressin, milrinone, levosimendan, etc.) within 30 days before the screening visit.
- 8) History of arterial or deep vein thrombosis within 6 months before dosing, or any spontaneous bleeding of any severity within 2 months before dosing.
- 9) Untreated mild or more severe obstructive sleep apnea history. 10）Previous or planned heart or lung transplant, or expected lifespan <12 months as assessed by the investigator.
- 11) Diagnosed with chronic obstructive pulmonary disease (COPD) or other clinically significant lung diseases.
- 12) Exclusion if there is evidence of interstitial lung disease (ILD) from a chest CT within 1 year before screening or a lung function test (PET) within 6 months before screening; if these test results are not available, or if the chest CT within 1 year shows mild or more severe ILD, a lung function test (PET) or chest CT must be done during the screening period, and patients with ILD detected are excluded.
- 13) Before administration, hemoglobin (Hb) > the upper limit of normal (ULN) for their gender or <90 g/L, platelet count ≤100×10⁹/L, neutrophils <1.5×10⁹/L, AST or ALT >3×ULN, total bilirubin >1.5×ULN, estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m² (defined according to CKD-EPI 2021 formula).
- 14) History of portal hypertension or chronic liver disease, including positive Hepatitis B surface antigen (HBsAg) and/or positive Hepatitis B core antibody (HBcAb) with HBV-DNA levels above the normal range; positive Hepatitis C virus (HCV) and positive HCV-RNA; positive HIV serology; positive Treponema pallidum antibody (TP-Ab) (if Treponema pallidum serology is positive, a non-Treponema pallidum serology test should be done, and if negative and judged by the investigator as a cured past syphilis infection, the patient can be included).
- 15) Currently participating in other clinical studies; or has participated in a medical device or drug clinical study within 30 days before screening (except those who only signed the ICF but did not receive investigational drug or device intervention), or still within 5 half-lives (t1/2) of an investigational product (whichever is longer).
- 16) Previously received treatment targeting the TGF-β superfamily (e.g., Sotatercept), including participation in clinical trials.
- 17) Known allergies to large molecule protein products/monoclonal antibodies, the study drug or its excipients, or drugs of the same type.
- 18) Started a cardiopulmonary rehabilitation exercise program within 90 days before screening, or planning to start one during the study (participants who have maintained a stable program and will continue during the study are eligible).
- 19) History of opportunistic infections (e.g., invasive candidiasis or Pneumocystis pneumonia within 6 months before dosing); severe local infections (e.g., cellulitis, abscess) or systemic infections (e.g., sepsis) within 4 weeks before screening.
- 20) Major surgery within 8 weeks before the first dose, or participants not fully recovered from previous surgery before the first dose.
- 21) If receiving corticosteroid therapy, any of the following within 30 days before the first dose: taken >20 mg/day of prednisone (or equivalent) or started a new dose/change in dose ≤20 mg/day, the participant is excluded; stable ≤20 mg/day prednisone (or equivalent) within 30 days before the first dose is allowed. For connective tissue disease-associated pulmonary arterial hypertension patients on immunosuppressive therapy, if the treatment has been stable for less than 3 months prior to dosing; any participant who has received CRA-T therapy is excluded.
- 22) History of malignancy or current malignancy (excluding basal cell carcinoma excised with no evidence of metastasis for 3 years, or treated cervical intraepithelial neoplasia with unknown recurrence status).
- 23) Autoimmune disease, except for PAH etiology-related diseases included in this study.
- 24) History of chronic kidney disease, or acute kidney injury requiring acute dialysis within 3 months before screening regardless of past kidney disease history.
- 25) Pregnant or breastfeeding women. 26) Participants deemed unsuitable for the study by the investigator.
Trial locations and contacts
29 sites in 1 country. Contact the study team or a site near you to ask about taking part.
29 sites in 1 country
China29 sites, 29 recruiting
- Not yet recruiting
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality
Xiqi Xu, 86+15300131702, 15300131702@163.com
- Not yet recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan
Jiang Li, 86+13975128898, 86+13975128898@163.com
- Not yet recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan
Yunshan Cao, 86+18980602149, chenyucheng2003@126.com
- Not yet recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan
Yucheng Chen, 86+18980602149, chenyucheng2003@126.com
- Not yet recruiting
Fujian Medical University Union Hospita
Fuzhou, Fujian
Mingfang Ye, 86+13365910160, xieheyemingfang@126.com
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
Zhicheng Jing, M.D., 86+020-83827812, jingzhicheng@gdph.org.cn
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
Xin Jang, M.D., 86+15910646886, jxcs83@163.com
- Not yet recruiting
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou
Wei Li, 86+13809482491, 602351694@qq.com
- Not yet recruiting
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Xiaogang Guo, 86+13867441856, gxg22222@zju.edu.cn
- Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang
Jian'an Wang, 86+13805786328, wangjianan111@zju.edu.cn
- Recruiting
The first hospital of Jilin University
Jilin City, Changchun
Hong Zhang, 86+18186870853, jhongzhang@foxmail.com
- Recruiting
The first hospital of Jilin University
Jilin City, Changchun
Weihua Zhang, 86+15804300983, Zwhcyzb@yahoo.com.cn
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shangdong
Qiushang JI, 86+13791123058, jiqius@aliyun.com
- Not yet recruiting
Kunming Yan'an Hospital
Kunming, Yunnan
Hailong Dai, 86+13888741228, 46944404@qq.com
- Recruiting
Gansu Provincial Hospital
Lanzhou, Gansu
Hongling Su, 86+13893141212, XFXGK2022@126.com
- Not yet recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Zeqi Zheng, 86+18679129668, zeqizheng@126.com
- Not yet recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality
Xin Pan, 86+13641937855, panxin805@163.com
- Not yet recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality
Lan Wang, 86+13651682766, wanglan198212@163.com
- Recruiting
Shanghai Tongji Hospital
Shanghai, Shanghai Municipality
Fadong Chen, 86+13918379479, chenfadong0819@163.com
- Not yet recruiting
General Hospital of the Northern Theater Command
Shenyang, Liaoning
Qi'guang Wang, 86+17790993368, wqg1993@163.com
- Not yet recruiting
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality
Tong Liu, 86+13902183163, liutongdoc@126.com
- Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality
Zhenwen Yang, 86+13920889629, yzwmd@hotmail.com
- Recruiting
Wuhan Asia Heart Hospital
Wuhan, Hubei
Hongmei Zhou, 86+18963980675, yxzhouhonggmei@aliyun.com
- Not yet recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei
Gangcheng Zhang, 86+18963980946, zgc@wahh.com.cn
- Not yet recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei
Tielong Chen, 86+13554466518, 530038676@qq.con
- Recruiting
Xiamen Hospital of T.C.M.
Xiamen, Fujian
Lianfa Chen, 86+13666057008, clf7008@163.com
- Recruiting
Xuzhou Central Hospital
Xuzhou, Jiangsu
Hongyun Ruan, 86+18952171643, hongyunruan@163.com
- Not yet recruiting
Fuwai Center China Cardiovascular Hospital
Zhengzhou, Henan
Chuanyu Gao, 86+13937165590, Gaocy6802@163.com
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Lu Zheng, 86+13592675327, zhenglu1114@163.com
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multiple-dose, Dose-escalation Phase Ib/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of IMC-003 Injection in Patients With Pulmonary Arterial Hypertension (PAH) Receiving Background Therapy.
This is a Phase Ib/IIa clinical study of IMC-003 treatment in pulmonary arterial hypertension (PAH) patients receiving background therapy
- Conditions
- Pulmonary Arterial Hypertension PAH
- Being tested
- IMC-003 and PAH background therapy, IMC-003 placebo and PAH background therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMC-003 and PAH background therapyDrug
Subjects will receive 8 injections of IMC-003 and will also need to have stable background treatment for pulmonary arterial hypertension.
IMC-003 placebo and PAH background therapyDrug
Subjects will receive 8 injections placebo of IMC-003 and will also need to have stable background treatment for pulmonary arterial hypertension.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: IMC-003 | Active comparator | Subjects will receive eight injection treatments with IMC-003, once every three weeks. Receives: Drug: IMC-003 and PAH background therapy |
| placebo of IMC-003 | Placebo comparator | Subjects will receive eight injection treatments with placebo of IMC-003, once every three weeks. Receives: Drug: IMC-003 placebo and PAH background therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase Ib
Primary Endpoints
- Safety and Tolerability: Incidence and frequency of adverse events (AEs) and serious adverse events (SAEs) (according to CTCAE v6.0 from NCI);
- abnormalities in vital signs, physical exams（The units for height are centimeters and for weight are kilograms ）, lab tests, 12-lead ECG, echocardiography, etc., before and after medication.
Primary Efficacy Endpoint
- Change in hemodynamic indicator pulmonary vascular resistance (PVR) from baseline at Week 24 of treatment.
Measured: 24 weeks
Phase IIa
Primary efficacy endpoint:
- Change in hemodynamic parameter pulmonary vascular resistance (PVR) from baseline after 24 weeks of treatment.
Safety endpoints:
- Occurrence and frequency of AE and SAE;
- Any abnormalities in vital signs, physical exams（The units for height are centimeters and for weight are kilograms ）, lab tests, 12-lead ECGs, and echocardiograms before and after treatment.
Measured: 24 weeks
Secondary outcomes (1)
Proportion of participants meeting composite improvement criteria . Other hemodynamic-related changes. Changes in heart MRI-related indicators. Changes in 6MWD. Changes in WHO FC classification. Changes in NT-proBNP. The rate at which the disease worsens
- At 24 weeks of treatment, the proportion of participants who achieved the composite improvement criteria :
- Six-minute walk distance increased by ≥30 meters from baseline
- NT-proBNP decreased by ≥30% from baseline, or NT-proBNP levels remained/achieved <300 ng/L
- WHO functional class improved by at least 1 level from baseline, or maintained at WHO FC II
- At 24 weeks of treatment, changes in other hemodynamic-related indicators from baseline
- At 24 weeks of treatment, changes in heart-related MRI indicators from baseline
- After treatment, assess the change in 6MWD from baseline at the end of the 2nd, 4th, 6th, and 8th treatment cycles
- After treatment, the change in WHO functional class from baseline at the end of each treatment cycle
- After treatment, the change in NT-proBNP from baseline at the end of each treatment cycle
- The rate of disease progression at 24 weeks of treatment
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start30 Apr 2026
- Primary completion31 Oct 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial Hypertension PAHStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhicheng Jing, M.D., Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07593027
- Sponsor's protocol ID
- IMC-003-Ⅱ-01
- Status last verified
- Jul 2026
- First submitted
- 9 May 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multiple-dose, Dose-escalation Phase Ib/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of IMC-003 Injection in Patients With Pulmonary Arterial Hypertension (PAH) Receiving Background Therapy.
- ClinicalTrials.gov ID
- NCT07593027
- Acronym / sponsor ID
- IMC-003-Ⅱ-01
- Conditions
- Pulmonary Arterial Hypertension PAH
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.University, hospital or other
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase Ib/IIa clinical study of IMC-003 treatment in pulmonary arterial hypertension (PAH) patients receiving background therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: IMC-003 | Active comparator | Drug: IMC-003 and PAH background therapySubjects will receive eight injection treatments with IMC-003, once every three weeks. |
| placebo of IMC-003 | Placebo comparator | Drug: IMC-003 placebo and PAH background therapySubjects will receive eight injection treatments with placebo of IMC-003, once every three weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Participants aged 18-75 years old (inclusive), any gender;
- Patients diagnosed with WHO Group 1 pulmonary arterial hypertension (PAH) via right heart catheterization (RHC) before dosing (see Appendix 1), including the following subtypes:
- Symptomatic pulmonary arterial hypertension, WHO functional class II or III ;
- Must also meet the following hemodynamic criteria:
- Pulmonary vascular resistance (PVR) measured by RHC within 10 days before initial dosing ≥5 Wood Units (400 dyn·sec·cm-5), prior RHC results before screening are acceptable if they meet study requirements;
Key exclusion criteria (27 listed)
- 1) Diagnosed with WHO Group 2, 3, 4, or 5 pulmonary hypertension. 2) Diagnosed with the following PAH subtypes in WHO Group 1:
- HIV-associated PAH
- Portal hypertension-associated PAH
- Schistosomiasis-associated PAH
- PAH associated with pulmonary veno-occlusive disease or pulmonary capillary hemangiomatosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMC-003 and PAH background therapySubjects will receive 8 injections of IMC-003 and will also need to have stable background treatment for pulmonary arterial hypertension. | Drug | Experimental: IMC-003 |
| IMC-003 placebo and PAH background therapySubjects will receive 8 injections placebo of IMC-003 and will also need to have stable background treatment for pulmonary arterial hypertension. | Drug | placebo of IMC-003 |
Primary outcome
Phase Ib
Time frame: 24 weeks
Primary Endpoints * Safety and Tolerability: Incidence and frequency of adverse events (AEs) and serious adverse events (SAEs) (according to CTCAE v6.0 from NCI); * abnormalities in vital signs, physical exams（The units for height are centimeters and for weight are kilograms ）, lab tests, 12-lead ECG, echocardiography, etc., before and after medication. Primary Efficacy Endpoint - Change in hemodynamic indicator pulmonary vascular resistance (PVR) from baseline at Week 24 of treatment.
Phase IIa
Time frame: 24 weeks
Primary efficacy endpoint: - Change in hemodynamic parameter pulmonary vascular resistance (PVR) from baseline after 24 weeks of treatment. Safety endpoints: * Occurrence and frequency of AE and SAE; * Any abnormalities in vital signs, physical exams（The units for height are centimeters and for weight are kilograms ）, lab tests, 12-lead ECGs, and echocardiograms before and after treatment.
1 secondary outcome
Proportion of participants meeting composite improvement criteria . Other hemodynamic-related changes. Changes in heart MRI-related indicators. Changes in 6MWD. Changes in WHO FC classification. Changes in NT-proBNP. The rate at which the disease worsens
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhicheng Jing, M.D. principal investigator
Guangdong Provincial People's Hospital
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IMC-003 and PAH background therapy in people with Pulmonary Arterial Hypertension PAH, run by ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd. at 29 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaojun Zhou (021-58356573, xiaojun.zhou@immunecarebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase Ib (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.