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

NCT06949020 | Not Yet Recruiting Phase 2

• 1 other identifier: JMKX003142-H201
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

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

Keywords

fluid retention; heart failure

Outcome Measures

Primary Outcomes (1)

• body weight

  5 days

Study Arms (4)

low dose group

EXPERIMENTAL

Drug: JMKX003142 Injection

median dose group

EXPERIMENTAL

Drug: JMKX003142 Injection

high dose group

EXPERIMENTAL

Drug: JMKX003142 Injection

placebo group

PLACEBO COMPARATOR

Drug: JMKX003142 placebo

Interventions

JMKX003142 Injection DRUG

JMKX003142 injection for experimental groups once daily for five days.

high dose group

JMKX003142 placebo DRUG

JMKX003142 placebo for placebo groups once daily for five days.

placebo group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Can fully understand the purpose and process of the study and voluntarily sign the informed consent form;
• Age ≥ 18 years old when signing the informed consent form;
• 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;
• The screening phase is currently undergoing or preparing to use one of the following diuretic therapy as background treatment during the run-in period:
• \) 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.
• \. After the background treatment in the run-in period, the subject still has the following two conditions:
• 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;
• During the import phase, the weight of D-1 does not change by more than 1.0 kg compared to D-3.

You may not qualify if:

• Edema caused by diseases other than heart failure；
• Subjects with ventricular assist devices during screening;
• Subjects diagnosed with active myocarditis, myocardial amyloidosis, hypertrophic cardiomyopathy (excluding dilated phase), or valve disease with obvious valve stenosis during screening;
• 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);
• Subjects with hypovolemia or suspected hypovolemia;
• Subject cannot feel thirst or have difficulty in fluid intake during screening;
• During screening, the systolic blood pressure is less than 90mmHg or the diastolic blood pressure is less than 60mmHg;
• Administered with tolvaptan 14days before randomization ；
• Pregnancy (female pregnancy test positive) or lactation period;

Sponsors & Collaborators

• Jemincare: lead

MeSH Terms

Conditions

Edema, Cardiac; Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Edema; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yang Zhang

CONTACT

+8618768467776; zhangyang@jemincare.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: April 29, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share