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

Jemincare

Status and phase: Completed; Phase 2

Conditions: Cardiac Edema

Treatments: Drug: JMKX003142 Injection; Drug: JMKX003142 placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06949020

JMKX003142-H201

Details and patient eligibility

About

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

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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160 participants in 4 patient groups, including a placebo group

low dose group

Experimental group

Treatment:

Drug: JMKX003142 Injection

Drug: JMKX003142 Injection

Drug: JMKX003142 Injection

median dose group

Experimental group

Treatment:

Drug: JMKX003142 Injection

Drug: JMKX003142 Injection

Drug: JMKX003142 Injection

high dose group

Experimental group

Treatment:

Drug: JMKX003142 Injection

Drug: JMKX003142 Injection

Drug: JMKX003142 Injection

placebo group

Placebo Comparator group

Treatment:

Drug: JMKX003142 placebo