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

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: Not yet recruiting
• Conditions: ADPKD (Autosomal Dominant Polycystic Kidney Disease)
• Intervention / Treatment: Drug: JMKX003142 tablets; Drug: JMKX003142 tablets; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
The effect of JMKX003142 treatment on placebo-corrected change from baseline QT interval (ΔΔQTc)	Up to 24 hours post dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Placebo-corrected Change From Baseline in Heart Rate After JMKX003142 treatment	Up to 72 hours post dose
Placebo-corrected Change From Baseline in QRS after JMKX003142 treatment	Up to72 hours post dose
Placebo-corrected Change From Baseline in PR Interval After JMKX003142 treatment	Up to 72 hours post dose
Number of Participants With Treatment-emergent Changes in T-wave Morphology and U-wave Presence	Up to 72 hours post dose
Incidence of adverse events to assess the safety of single-dose administration of JMKX003142	Up to 72 hours post dose
Maximum Observed Plasma Concentration (Cmax) of JMKX003142	Up to 72 hours post dose
Time to Maximum Observed Plasma Concentration (Tmax) of JMKX003142	Up to 72 hours post dose
Apparent Terminal Elimination Half-life (T1/2) of JMKX003142	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	Up to 72 hours post dose
AUC From Time 0 to Infinity (AUCinf) for JMKX003142	Up to 72 hours post dose

Collaborators and Investigators

• Sponsor: Jemincare
• Collaborators: Zhejiang Hangyu Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): March 27, 2026
• Primary Completion (Estimated): May 14, 2026
• Study Completion (Estimated): June 23, 2026

Study Registration Dates

• First Submitted: March 10, 2026
• First Submitted That Met QC Criteria: March 10, 2026
• First Posted (Actual): March 13, 2026

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ciliopathies; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genetic Diseases, Inborn; Congenital Abnormalities; Abnormalities, Multiple; Kidney Diseases, Cystic; Polycystic Kidney Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Polycystic Kidney, Autosomal Dominant
• Other Study ID 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