A Phase Ⅰb/Ⅱa Clinical Study of IMC-003 Injection for the Treatment of Pulmonary Arterial Hypertension Receiving Background Therapy.

May 15, 2026 updated by: ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Not yet recruiting
        • Xuanwu Hospital Capital Medical University
        • Contact:
    • Changchun
      • Jilin, Changchun, China
        • Not yet recruiting
        • The First Hospital of Jilin University
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China
        • Not yet recruiting
        • Fujian Medical University Union Hospita
        • Contact:
      • Xiamen, Fujian, China
        • Not yet recruiting
        • Xiamen Hospital of T.C.M.
        • Contact:
    • Gansu
      • Lanzhou, Gansu, China
        • Not yet recruiting
        • Gansu Provincial Hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
    • Guizhou
      • Guiyang, Guizhou, China
        • Not yet recruiting
        • The Affiliated Hospital of Guizhou Medical University
        • Contact:
    • Henan
      • Zhengzhou, Henan, China
        • Not yet recruiting
        • The first affiliated hospital of Zhengzhou university
        • Contact:
      • Zhengzhou, Henan, China
        • Not yet recruiting
        • Fuwai Center China Cardiovascular Hospital
        • Contact:
    • Hubei
      • Wuhan, Hubei, China
        • Not yet recruiting
        • Zhongnan Hospital of Wuhan University
        • Contact:
      • Wuhan, Hubei, China
        • Not yet recruiting
        • Wuhan Asia Heart Hospital
        • Contact:
    • Hunan
      • Changsha, Hunan, China
        • Not yet recruiting
        • The second Xiangya hospital of central south university
        • Contact:
    • Jiangsu
      • Xuzhou, Jiangsu, China
        • Not yet recruiting
        • Xuzhou Central Hospital
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Not yet recruiting
        • The First Affiliated Hospital of NanChang University
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China
        • Not yet recruiting
        • General Hospital of the Northern Theater Command
        • Contact:
    • Shangdong
      • Jinan, Shangdong, China
        • Not yet recruiting
        • Qilu Hospital of Shandong University
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Not yet recruiting
        • Shanghai Pulmonary Hospital
        • Contact:
      • Shanghai, Shanghai Municipality, China
        • Not yet recruiting
        • Shanghai Tongji Hospital
        • Contact:
      • Shanghai, Shanghai Municipality, China
        • Not yet recruiting
        • Shanghai Chest Hospital
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China
        • Not yet recruiting
        • West China Hospital, Sichuan University
        • Contact:
      • Chengdu, Sichuan, China
        • Not yet recruiting
        • Sichuan Provincial People's Hospital
        • Contact:
          • Mengchang Yang
          • Phone Number: 86+18140049936
          • Email: ymc@126.com
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China
        • Not yet recruiting
        • The Second Hospital Of Tianjin Medical University
        • Contact:
      • Tianjin, Tianjin Municipality, China
        • Not yet recruiting
        • Tianjin Medical University General Hospital
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China
        • Not yet recruiting
        • Kunming Yan'an Hospital
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Not yet recruiting
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Contact:
      • Hangzhou, Zhejiang, China
        • Not yet recruiting
        • The First Affiliated Hospital of Zhejiang University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age screening between 18 and 75 years (inclusive), regardless of gender.
  2. Patients diagnosed with WHO Group 1 pulmonary arterial hypertension (PAH) confirmed by right heart catheterization (RHC) before initial dosing (see Appendix 1), including the following subtypes: idiopathic PAH; heritable PAH; drug- or toxin-induced PAH; PAH associated with connective tissue diseases that is inactive; PAH associated with simple congenital heart defects with systemic-to-pulmonary shunts, at least one year post-correction surgery.
  3. Symptomatic pulmonary arterial hypertension, WHO functional class II or III.
  4. Must also meet the following hemodynamic criteria: mean pulmonary arterial pressure (mPAP) ≥25 mmHg at rest; pulmonary artery wedge pressure (PAWP) ≤15 mmHg.
  5. Pulmonary vascular resistance (PVR) ≥5 Wood Units (400 dyn·sec·cm-5) by RHC before the first dose, results from pre-screening RHC are acceptable (if they meet the study requirements).
  6. Receiving stable doses of background PAH therapy (i.e., each therapy's individualized target dose has been achieved and stable for at least 90 days before initial dosing).
  7. Six-minute walk distance (6MWD) during screening ≥150 meters and ≤450 meters.
  8. Female participants of childbearing potential must have a negative serum pregnancy test before dosing and agree to undergo regular urine or serum pregnancy tests (any one) during the treatment period; agree to use highly effective contraception before dosing, during the treatment period (including dosing interruptions), and for 16 weeks (112 days) after the last dose, and to avoid blood donation or egg donation within 16 weeks (112 days) after the last dose.
  9. Male participants agree to use condoms, defined as using latex condoms or non-latex (non-animal membrane) condoms (e.g., polyurethane) during sexual intercourse with pregnant or childbearing potential women during treatment (including dosing interruptions) and for 16 weeks (112 days) after the last dose, even if a successful vasectomy has been performed, and to avoid sperm donation within this period.
  10. Participants understand and comply with the study procedures, voluntarily participate, and sign the informed consent form.

Exclusion Criteria:

  1. Diagnosed with pulmonary hypertension of WHO Group 2, 3, 4, or 5.
  2. Diagnosed with the following PAH subtypes of WHO Group 1: HIV-associated PAH, portal hypertension-associated PAH, schistosomiasis-associated PAH, PAH related to pulmonary veno-occlusive disease or pulmonary capillary hemangiomatosis, patients with PAH known to have a positive acute pulmonary vasoreactivity test.
  3. Poorly controlled hypertension after screening: seated systolic BP >160 mmHg or seated diastolic BP >100 mmHg, or pre-dose systolic BP <90 mmHg on C1D1.
  4. Pre-dose electrocardiogram (ECG) Fridericia-corrected QT interval (QTcF) ≥470 ms for men, ≥480 ms for women; or personal or family history of long QT syndrome (LQTS) or sudden cardiac death.
  5. Untreated mild or more severe obstructive sleep apnea.
  6. Previously underwent or plans to undergo heart or cardiopulmonary transplantation, or expected lifespan <12 months as assessed by the investigator.
  7. Diagnosed with chronic obstructive pulmonary disease (COPD) or other clinically significant lung disease.
  8. Evidence of interstitial lung disease (ILD) based on chest CT within 1 year before screening or pulmonary function test (PET) within 6 months before screening will lead to exclusion; if the above tests are not available, or chest CT within 1 year shows mild or greater ILD, a PET or chest CT should be performed during the screening period, and patients with evidence of ILD will be excluded.
  9. Pre-dose hemoglobin (Hb) above the sex-specific upper limit of normal (ULN) or <90 g/L, platelet count ≤100 × 10^9/L, neutrophils <1.5 × 10^9/L, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 × ULN, total bilirubin >1.5 × ULN, estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m^2.
  10. History of portal hypertension or chronic liver disease, including Hepatitis B Surface Antigen (HBsAg) positive, and/or Hepatitis B Core Antibody (HBcAb) positive and Hepatitis Bvirus-Deoxyribonucleic acid HBV-DNA) titers outside the normal range; Hepatitis C virus (HCV) positive and hepatitis C virus ribonucleic acid (HCV-RNA) positive; Human Immunodeficiency Virus (HIV) seroresponse; Treponema pallidum antibody (TP-Ab) positive (if Treponema pallidum serology test is positive, further non-Treponema pallidum serology test, which is negative and judged by the investigator to be cured of syphilis in the past is eligible for inclusion).
  11. are participating in other clinical studies; or have participated in clinical studies of medical devices or other drugs within 30 days before screening (except for those who have only signed the ICF and have not received the investigational drug or device intervention), or are still within 5 half-lives (t1/2) of the investigational drug (whichever is longer).
  12. Previous treatment targeting the TGF-β superfamily (e.g., Sotatercept) (including participation in a clinical trial).
  13. Known participant has a prior allergy to macromolecular protein preparations/monoclonal antibodies, known hypersensitivity to the investigational drug or its excipients, or the same type of drug.
  14. History of opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia within 6 months prior to dosing); Severe local infection (e.g., cellulitis, abscess) or systemic infection (e.g., sepsis) within 4 weeks prior to screening.
  15. History of malignancy or current malignancy (excluding basal cell carcinoma that has been resected with no evidence of metastatic disease for 3 years, or cervical intraepithelial neoplasia that has been treated and is not known to have recurred).
  16. History of chronic kidney disease prior to screening, or acute renal failure requiring acute dialysis within 3 months prior to screening, regardless of whether there was a previous history of kidney disease.
  17. Females who are pregnant or breastfeeding.
  18. Participants who are considered unsuitable for the study in the opinion of the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Experimental: IMC-003
Subjects will receive eight injection treatments with IMC-003, once every three weeks.
Drug: IMC-003 and PAH background therapy
Subjects will receive 8 injections of IMC-003 and will also need to have stable background treatment for pulmonary arterial hypertension.
Placebo Comparator: placebo of IMC-003
Subjects will receive eight injection treatments with placebo of IMC-003, once every three weeks.
Drug: IMC-003 placebo and PAH background therapy
Subjects will receive 8 injections placebo of IMC-003 and will also need to have stable background treatment for pulmonary arterial hypertension.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate the safety and tolerability of multiple subcutaneous injections of IMC-003 in patients with pulmonary arterial hypertension, providing a basis for selecting the Recommended Phase 2 Dose (RP2D) of this product.
Time Frame: Day169
Day169

Secondary Outcome Measures

Outcome Measure
Time Frame
At 24 weeks of treatment, the change in hemodynamic indicator pulmonary vascular resistance (PVR) from baseline.
Time Frame: Day169
Day169

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.

Investigators

  • Principal Investigator: Zhicheng Jing, M.D., Guangdong Provincial People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2026

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

November 30, 2027

Study Registration Dates

First Submitted

May 9, 2026

First Submitted That Met QC Criteria

May 15, 2026

First Posted (Actual)

May 18, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 15, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • IMC-003-Ⅱ-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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