A Dose-finding Study of JMKX003142 in Treatment of Cardiac Edema

NCT ID: NCT06949020

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2027-05-31

Brief Summary

To Evaluate the Safety, Efficacy, and Pharmacokinetic/Pharmacodynamics Characteristics of JMKX003142 injection Administered Randomly,Double-blind, Placebo-controlled Study in Chinese Cardiacl Edema Patients.

Conditions

Cardiac Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

low dose group

Group Type: EXPERIMENTAL

JMKX003142 Injection

Intervention Type: DRUG

JMKX003142 injection for experimental groups once daily for five days.

median dose group

Group Type: EXPERIMENTAL

JMKX003142 Injection

Intervention Type: DRUG

JMKX003142 injection for experimental groups once daily for five days.

high dose group

Group Type: EXPERIMENTAL

JMKX003142 Injection

Intervention Type: DRUG

JMKX003142 injection for experimental groups once daily for five days.

placebo group

Group Type: PLACEBO_COMPARATOR

JMKX003142 placebo

Intervention Type: DRUG

JMKX003142 placebo for placebo groups once daily for five days.

Interventions

JMKX003142 Injection

JMKX003142 injection for experimental groups once daily for five days.

Intervention Type: DRUG

JMKX003142 Injection

JMKX003142 injection for experimental groups once daily for five days.

Intervention Type: DRUG

JMKX003142 Injection

JMKX003142 injection for experimental groups once daily for five days.

Intervention Type: DRUG

JMKX003142 placebo

JMKX003142 placebo for placebo groups once daily for five days.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Can fully understand the purpose and process of the study and voluntarily sign the informed consent form;

2. Age ≥ 18 years old when signing the informed consent form;

3. At the screening stage, it has been definitely diagnosed as heart failure, and it is combined with one of the following clinical manifestations related to body fluid retention: edema of both lower limbs, jugular vein engorgement, pulmonary congestion;

4. The screening phase is currently undergoing or preparing to use one of the following diuretic therapy as background treatment during the run-in period:

1) At least 40mg/day of furosemide equivalent loop diuretics; 2) Any dose of loop diuretics combined with thiazide diuretics; 3) Any dose of loop diuretics combined with aldosterone receptor antagonists or other potassium sparing diuretics.

5. After the background treatment in the run-in period, the subject still has the following two conditions:

1. One of the following clinical manifestations related to fluid retention still exists after the induction phase treatment: edema of both lower limbs, jugular vein dilatation, pulmonary congestion;

2. During the import phase, the weight of D-1 does not change by more than 1.0 kg compared to D-3.

Exclusion Criteria

1. Edema caused by diseases other than heart failure；

2. Subjects with ventricular assist devices during screening;

3. Subjects diagnosed with active myocarditis, myocardial amyloidosis, hypertrophic cardiomyopathy (excluding dilated phase), or valve disease with obvious valve stenosis during screening;

4. Acute myocardial infarction occurred within 30 days prior to screening; subjects with a history of persistent ventricular tachycardia or ventricular fibrillation within the 30 days prior to screening (those without implantable defibrillators); History of cerebrovascular disease within 6 months prior to screening (excluding asymptomatic cerebral infarction);

5. Subjects with hypovolemia or suspected hypovolemia;

6. Subject cannot feel thirst or have difficulty in fluid intake during screening;

7. During screening, the systolic blood pressure is less than 90mmHg or the diastolic blood pressure is less than 60mmHg;

8. Administered with tolvaptan 14days before randomization ；

9. Pregnancy (female pregnancy test positive) or lactation period;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jemincare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Yang Zhang

Role: CONTACT

zhangyang@jemincare.com

+8618768467776

Other Identifiers

JMKX003142-H201

Identifier Type: -

Identifier Source: org_study_id