A Study to Investigate the Effects of JMKX003142 on QTc Interval in Healthy Adults

March 10, 2026 updated by: Jemincare

A Single-center, Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Evaluate the Effect of a Single-dose of JMKX003142 on QTc Intervals in Healthy Participants

The primary objective of this study is to assess the effect of a therapeutic and supratherapeutic oral dose of JMKX003142 on the corrected cardiac QT interval relative to a placebo in healthy participants

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Participants must be able to return to the study center for follow-up visits as required by the protocol and be willing to comply with study policies, procedures, and constraints. They must be able to communicate effectively with the investigator, complete study-related materials, and understand the contents of the Informed Consent Form (ICF). A written ICF must be signed before any study-specific procedures are performed.
  2. Healthy Chinese males or females based on medical history and physical examination. At the time of signing the informed consent form (ICF), participants must be aged 18 to 45 years (inclusive), with a body weight ≥ 50 kg and a body mass index (BMI) between 19.0 and 28.0 $kg/m^2 (inclusive).
  3. Participants' health status will be determined by the investigator based on medical history, physical examination, clinical laboratory tests, and 12-lead electrocardiogram (ECG). All test results must be confirmed by the investigator as either normal or abnormal without clinical significance (NCS).
  4. Participants of childbearing potential must have no plans to conceive, freeze, or donate sperm/eggs from the time of signing the informed consent form (ICF) until 3 months after the last dose, and must agree to use highly effective contraception methods.

Exclusion Criteria:

  1. History or presence of clinically significant diseases, including but not limited to: cardiovascular, respiratory, gastrointestinal, hematological, genitourinary, endocrine and metabolic, neurological, psychiatric, musculoskeletal, dermatological, lymphatic, or immunological systems, or diseases of the sense organs, as well as current systemic or local acute/chronic infections.
  2. Participants with any condition that increases the risk of bleeding, such as acute gastritis or active ulcers with bleeding, clinically significant thrombocytopenia or anemia, active pathological bleeding, or a history of intracranial hemorrhage.
  3. Vital signs at screening that meet any of the following criteria: systolic blood pressure (SBP) ≥ 140 mmHg or < 90 mmHg; diastolic blood pressure (DBP) ≥ 90 mmHg or < 50 mmHg; pulse rate > 100 bpm or < 50 bpm; or axillary temperature > 37.2°C.
  4. History of QTc interval prolongation, or any clinically significant abnormal ECG findings at screening as determined by the investigator, or QTcF ≥ 450 ms, or QRS duration > 120 ms, or PR interval ≥ 200 ms.
  5. Clinical laboratory test results at screening showing serum potassium, magnesium, or calcium levels outside the normal range and judged by the investigator to be clinically significant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part 1
Drug: JMKX003142 tablets
Participants will receive single of JMKX003142 6mg
Drug: JMKX003142 tablets
Participants will receive single of JMKX003142 30mg
Drug: Placebo
Participants will receive single of Placebo
Experimental: Part 2
Drug: JMKX003142 tablets
Participants will receive single of JMKX003142 6mg
Drug: JMKX003142 tablets
Participants will receive single of JMKX003142 30mg
Drug: Placebo
Participants will receive single of Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The effect of JMKX003142 treatment on placebo-corrected change from baseline QT interval (ΔΔQTc)
Time Frame: Up to 24 hours post dose
Up to 24 hours post dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Placebo-corrected Change From Baseline in Heart Rate After JMKX003142 treatment
Time Frame: Up to 72 hours post dose
Up to 72 hours post dose
Placebo-corrected Change From Baseline in QRS after JMKX003142 treatment
Time Frame: Up to72 hours post dose
Up to72 hours post dose
Placebo-corrected Change From Baseline in PR Interval After JMKX003142 treatment
Time Frame: Up to 72 hours post dose
Up to 72 hours post dose
Number of Participants With Treatment-emergent Changes in T-wave Morphology and U-wave Presence
Time Frame: Up to 72 hours post dose
Up to 72 hours post dose
Incidence of adverse events to assess the safety of single-dose administration of JMKX003142
Time Frame: Up to 72 hours post dose
Up to 72 hours post dose
Maximum Observed Plasma Concentration (Cmax) of JMKX003142
Time Frame: Up to 72 hours post dose
Up to 72 hours post dose
Time to Maximum Observed Plasma Concentration (Tmax) of JMKX003142
Time Frame: Up to 72 hours post dose
Up to 72 hours post dose
Apparent Terminal Elimination Half-life (T1/2) of JMKX003142
Time Frame: Up to 72 hours post dose
Up to 72 hours post dose
Area Under the Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUC0-t) for JMKX003142
Time Frame: Up to 72 hours post dose
Up to 72 hours post dose
AUC From Time 0 to Infinity (AUCinf) for JMKX003142
Time Frame: Up to 72 hours post dose
Up to 72 hours post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jemincare

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Zhejiang Hangyu Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 27, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 14, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 23, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JMKX003142-104

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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