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

Efficacy and Safety of JMKX003142 Injection in Heart Failure Patients With Volume Overload：A Phase II, Randomized, Double-blind, Placebo-controlled Study

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

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiac Edema
• Intervention / Treatment: Drug: JMKX003142 Injection; Drug: JMKX003142 placebo

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yang Zhang; Phone Number: +8618768467776; Email: zhangyang@jemincare.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo group	Drug: JMKX003142 placebo; JMKX003142 placebo for placebo groups once daily for five days.
Experimental: low dose group	Drug: JMKX003142 Injection; JMKX003142 injection for experimental groups once daily for five days.
Experimental: high dose group	Drug: JMKX003142 Injection; JMKX003142 injection for experimental groups once daily for five days.
Experimental: median dose group	Drug: JMKX003142 Injection; JMKX003142 injection for experimental groups once daily for five days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
body weight	5 days

Collaborators and Investigators

• Sponsor: Jemincare

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: April 22, 2025
• First Submitted That Met QC Criteria: April 22, 2025
• First Posted (Actual): April 29, 2025

Study Record Updates

• Last Update Posted (Actual): April 29, 2025
• Last Update Submitted That Met QC Criteria: April 22, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: heart failure; fluid retention
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure; Edema; Edema, Cardiac
• Other Study ID Numbers: JMKX003142-H201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No