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

NCT07593027 | Recruiting Phase 1

• 1 other identifier: IMC-003-Ⅱ-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 32

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Day169

Secondary Outcomes (1)

• At 24 weeks of treatment, the change in hemodynamic indicator pulmonary vascular resistance (PVR) from baseline.

  Day169

Study Arms (2)

Experimental: IMC-003

ACTIVE COMPARATOR

Subjects will receive eight injection treatments with IMC-003, once every three weeks.

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.

Drug: IMC-003 placebo and PAH background therapy

Interventions

IMC-003 and PAH background therapy DRUG

Subjects will receive 8 injections of IMC-003 and will also need to have stable background treatment for pulmonary arterial hypertension.

Experimental: IMC-003

IMC-003 placebo and PAH background therapy DRUG

Subjects will receive 8 injections placebo of IMC-003 and will also need to have stable background treatment for pulmonary arterial hypertension.

placebo of IMC-003

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age screening between 18 and 75 years (inclusive), regardless of gender.
• 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.
• Symptomatic pulmonary arterial hypertension, WHO functional class II or III.
• Must also meet the following hemodynamic criteria: mean pulmonary arterial pressure (mPAP) ≥25 mmHg at rest; pulmonary artery wedge pressure (PAWP) ≤15 mmHg.
• 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).
• 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).
• Six-minute walk distance (6MWD) during screening ≥150 meters and ≤450 meters.
• 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.
• 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.
• Participants understand and comply with the study procedures, voluntarily participate, and sign the informed consent form.

You may not qualify if:

• Diagnosed with pulmonary hypertension of WHO Group 2, 3, 4, or 5.
• 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.
• 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.
• 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.
• Untreated mild or more severe obstructive sleep apnea.
• Previously underwent or plans to undergo heart or cardiopulmonary transplantation, or expected lifespan \<12 months as assessed by the investigator.
• Diagnosed with chronic obstructive pulmonary disease (COPD) or other clinically significant lung disease.
• 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.
• 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).
• Previous treatment targeting the TGF-β superfamily (e.g., Sotatercept) (including participation in a clinical trial).
• 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.
• 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.
• 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).
• 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.
• Females who are pregnant or breastfeeding.

Sponsors & Collaborators

• ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.: lead

Study Sites (32)

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, China

NOT YET RECRUITING

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, China

NOT YET RECRUITING

The first hospital of Jilin University

Jilin, Changchun, China

NOT YET RECRUITING

The first hospital of Jilin University

Jilin, Changchun, China

NOT YET RECRUITING

Fujian Medical University Union Hospita

Fuzhou, Fujian, China

NOT YET RECRUITING

Xiamen Hospital of T.C.M.

Xiamen, Fujian, China

NOT YET RECRUITING

Gansu Provincial Hospital

Lanzhou, Gansu, China

NOT YET RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

RECRUITING

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

NOT YET RECRUITING

Fuwai Center China Cardiovascular Hospital

Zhengzhou, Henan, China

NOT YET RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

NOT YET RECRUITING

Wuhan Asia Heart Hospital

Wuhan, Hubei, China

NOT YET RECRUITING

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

NOT YET RECRUITING

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

NOT YET RECRUITING

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

NOT YET RECRUITING

Xuzhou Central Hospital

Xuzhou, Jiangsu, China

NOT YET RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

NOT YET RECRUITING

General Hospital of the Northern Theater Command

Shenyang, Liaoning, China

NOT YET RECRUITING

Qilu Hospital of Shandong University

Jinan, Shangdong, China

NOT YET RECRUITING

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

Shanghai Tongji Hospital

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

NOT YET RECRUITING

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

NOT YET RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, China

NOT YET RECRUITING

The Second Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, China

NOT YET RECRUITING

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

NOT YET RECRUITING

Kunming Yan'an Hospital

Kunming, Yunnan, China

NOT YET RECRUITING

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

NOT YET RECRUITING

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

NOT YET RECRUITING

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

NOT YET RECRUITING

Study Officials

• Zhicheng Jing, M.D.

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaojun Zhou

CONTACT

021-58356573; xiaojun.zhou@immunecarebio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2026
• First Posted: May 18, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (32)