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

Phase 2

Not yet recruiting

• Conditions: Cardiac Edema
• Interventions: Drug: JMKX003142 Injection; Drug: JMKX003142 placebo

• Registration Number: NCT06949020
• Lead Sponsor: Jemincare

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-22
• Study First Submitted QC: 2025-04-22
• Last Update Submitted: 2025-04-22
• Study First Posted: 2025-04-29
• Last Update Posted: 2025-04-29
• Study Start: 2025-06-01
• Primary Completion: 2027-01-31
• Study Completion: 2027-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 160

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:

6. 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;

7. 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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low dose group	JMKX003142 Injection	-
median dose group	JMKX003142 Injection	-
high dose group	JMKX003142 Injection	-
placebo group	JMKX003142 placebo	-

Primary Outcome Measures

Name	Time	Method
body weight	5 days