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: 29

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 (2)

• 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.

  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.

  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

  24 weeks

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:

• 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;
• 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).

You may not qualify if:

• \) 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).
• \) 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.
• \) 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.
• \) Use of IV positive inotropic agents (such as dobutamine, dopamine, norepinephrine, vasopressin, milrinone, levosimendan, etc.) within 30 days before the screening visit.
• \) History of arterial or deep vein thrombosis within 6 months before dosing, or any spontaneous bleeding of any severity within 2 months before dosing.
• \) 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.
• \) Diagnosed with chronic obstructive pulmonary disease (COPD) or other clinically significant lung diseases.
• \) 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).
• \) 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).
• \) 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).

Sponsors & Collaborators

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

Study Sites (29)

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, China

NOT YET RECRUITING

The first hospital of Jilin University

Jilin City, Changchun, China

RECRUITING

The first hospital of Jilin University

Jilin City, Changchun, China

RECRUITING

Fujian Medical University Union Hospita

Fuzhou, Fujian, China

NOT YET RECRUITING

Xiamen Hospital of T.C.M.

Xiamen, Fujian, China

RECRUITING

Gansu Provincial Hospital

Lanzhou, Gansu, China

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

RECRUITING

Wuhan Asia Heart Hospital

Wuhan, Hubei, China

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

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

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

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

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 Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (29)