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

NCT07470177 | Not Yet Recruiting Phase 1

• 1 other identifier: JMKX003142-104
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

ADPKD (Autosomal Dominant Polycystic Kidney Disease)

Outcome Measures

Primary Outcomes (1)

• The effect of JMKX003142 treatment on placebo-corrected change from baseline QT interval (ΔΔQTc)

  Up to 24 hours post dose

Secondary Outcomes (10)

• 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

Study Arms (2)

Part 1

EXPERIMENTAL

Drug: JMKX003142 tablets; Drug: Placebo

Part 2

EXPERIMENTAL

Drug: JMKX003142 tablets; Drug: Placebo

Interventions

JMKX003142 tablets DRUG

Participants will receive single of JMKX003142 6mg

Part 1

Placebo DRUG

Participants will receive single of Placebo

Part 1; Part 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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).
• 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).
• 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.

You may not qualify if:

• 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.
• 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.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Jemincare: lead
• Zhejiang Hangyu Pharmaceutical Co., Ltd.: collaborator

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 13, 2026
• Study Start: March 27, 2026
• Primary Completion: May 14, 2026
• Study Completion: June 23, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03