ADPKD (Autosomal Dominant Polycystic Kidney Disease)Phase 1NCT07470177
A Study to Investigate the Effects of JMKX003142 on QTc Interval in Healthy Adults
A Phase 1 study testing JMKX003142 tablets in people with ADPKD (Autosomal Dominant Polycystic Kidney Disease), run by Jemincare.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- ADPKD (Autosomal Dominant Polycystic Kidney Disease)
- What is being tested?
- JMKX003142 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 27 Mar 2026to 23 Jun 2026
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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
- Being tested
- JMKX003142 tablets, Placebo
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JMKX003142 tabletsDrug
Participants will receive single of JMKX003142 6mg
JMKX003142 tabletsDrug
Participants will receive single of JMKX003142 30mg
PlaceboDrug
Participants will receive single of Placebo
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | Not described Receives: Drug: JMKX003142 tablets; Drug: Placebo |
| Part 2 | Experimental | Not described Receives: Drug: JMKX003142 tablets; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of JMKX003142 treatment on placebo-corrected change from baseline QT interval (ΔΔQTc)
Measured: Up to 24 hours post dose
Secondary outcomes (10)
Placebo-corrected Change From Baseline in Heart Rate After JMKX003142 treatment
Measured: Up to 72 hours post dose
Placebo-corrected Change From Baseline in QRS after JMKX003142 treatment
Measured: Up to72 hours post dose
Placebo-corrected Change From Baseline in PR Interval After JMKX003142 treatment
Measured: Up to 72 hours post dose
Number of Participants With Treatment-emergent Changes in T-wave Morphology and U-wave Presence
Measured: Up to 72 hours post dose
Incidence of adverse events to assess the safety of single-dose administration of JMKX003142
Measured: Up to 72 hours post dose
Maximum Observed Plasma Concentration (Cmax) of JMKX003142
Measured: Up to 72 hours post dose
Time to Maximum Observed Plasma Concentration (Tmax) of JMKX003142
Measured: Up to 72 hours post dose
Apparent Terminal Elimination Half-life (T1/2) of JMKX003142
Measured: 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
Measured: Up to 72 hours post dose
AUC From Time 0 to Infinity (AUCinf) for JMKX003142
Measured: Up to 72 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start27 Mar 2026 (estimated)
- Primary completion14 May 2026 (estimated)
- Study completion23 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADPKD (Autosomal Dominant Polycystic Kidney Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jemincare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zhejiang Hangyu Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07470177
- Sponsor's protocol ID
- JMKX003142-104
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No