ADPKD (Autosomal Dominant Polycystic Kidney Disease)Phase 1NCT07909070
A Study to Investigate the Pharmacokinetics of JMKX003142 in Healthy Participants and Participants With Hepatic Impairment
A Phase 1 study testing JMKX003142 in people with ADPKD (Autosomal Dominant Polycystic Kidney Disease) and Renal Edema, run by Jemincare.
Trial summary
The primary purpose of this study is to evaluate the plasma PK of JMKX003142 following a single dose in participants with mild and moderate hepatic impairment compared to matched healthy participants with normal hepatic function. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- ADPKD (Autosomal Dominant Polycystic Kidney Disease), Renal Edema
- What is being tested?
- JMKX003142
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2026to 30 Sep 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All Participants:
- The participant is able to understand the content of this trial and is willing to comply with the policies, procedures, and constraints of the study, and a written informed consent form must be signed by the subject or a legally authorized representative before any study procedure is performed.
- At the time of signing the informed consent form, aged 18 to 75 years (inclusive), with body weight ≥50 kg for males or ≥45 kg for females, and body mass index (BMI) 18.0 to 30.0 kg/m² (inclusive).
- At screening, all examinations (including physical examination, vital signs, complete blood count, urinalysis, blood biochemistry, coagulation function, electrocardiogram, chest X-ray, abdominal ultrasonography, etc.) were judged by the investigator to be suitable for participation in this study.
- Female participants of childbearing potential with a negative pregnancy test result during the screening period or who are non-lactating; participants of childbearing potential with no plans for conception, cryopreservation, or donation of sperm or ova from the time of informed consent signing until 3 months after the last dose, and who agree to use effective contraception.
- Hepatically-Impaired Participants Only :
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- Participant with chronic hepatic impairment due to viral hepatitis, alcoholic liver disease, autoimmune hepatitis, or other primary liver diseases.
- Classified as Child-Pugh class A (score 5-6, cohort 1) or class B (score 7-9, cohort 2) by the Child-Pugh scoring system at screening, and had not received albumin within 14 days prior to screening.
- Participant with documented stable hepatic impairment (for ≥1 month) based on medical history, physical examination, laboratory testing, or imaging, who either have not taken any medication within 2 weeks prior to screening or, if long-term treatment is required for hepatic impairment and/or concomitant diseases, have had stable medication for at least 4 weeks prior to initiation of the study drug (stable medication to be determined by the investigator, excluding medications prohibited by the protocol).
Who cannot join
- All Participants:
- Allergy to the active ingredients and excipients of JMKX003142, or a history of allergy to two or more substances.
- Participant with clinically significant diseases, including but not limited to: circulatory, respiratory, digestive, urinary and reproductive, endocrine, nervous, and other relevant systems, or diseases or conditions that the investigator considers may affect the study results (except for participant who had impaired liver function and its complications).
- Effect of drug absorption (e.g., dysphagia, gastrointestinal resection, ulcerative colitis, symptomatic or inflammatory bowel disease, chronic diarrhea, and intestinal obstruction, among other gastrointestinal diseases).
- Participant with severe active infection, gastrointestinal surgery, or other major surgery within 4 weeks prior to screening.
- Participant with a history of Hemophobia and Fear of needles, unable to draw blood.
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- Participant who donated or loss blood ≥400 mL within 3 months prior to screening, or who received blood transfusions or blood products.
- Participant who administered any study drug within 3 months prior to screening, or who are currently participating in another clinical trial.
- History of drug dependence/abuse, or a positive drug screen.
- Participant who smoked >5 cigarettes per day within the 3 months prior to screening, or who are unable to commit to abstaining from smoking/tobacco products during the trial, or who have a positive nicotine screening test.
- History of alcoholism or heavy alcohol consumption within 6 months prior to screening [>14 units of alcohol per week: 1 unit ≈ 10 mL of pure alcohol, equivalent to approximately 285 mL of beer (3.5% ABV), 25 mL of spirits (40% ABV), or 100 mL of wine (10% ABV)]; or inability to abstain from alcohol during the trial; or a positive breath alcohol test.
- Consumption of grapefruit juice or methylxanthine-rich foods or beverages (e.g., coffee, tea, cola, chocolate, energy drinks) within 3 days prior to dosing, or Engagement in strenuous exercise or other factors that may affect drug absorption, distribution, metabolism, or excretion.
- Use of any medication (including prescription drugs, over-the-counter drugs, traditional Chinese medicine, vitamins, or dietary supplements) within 14 days prior to dosing (or 5 half-lives, whichever is longer); except for stable medication use in subjects with hepatic impairment.
- Use of any drug that inhibits or induces the activity of hepatic drug-metabolizing enzymes within 14 days prior to screening (see Appendix 5, Section 10.5 for details.
- Clinically significant ECG abnormalities at screening, including tachycardia or bradycardia requiring pharmacological treatment, second- or third-degree atrioventricular block, or prolonged QTcF interval (corrected by Fridericia's formula, QTcF = QT/RR^(1/3), rounded to the nearest integer) (male QTcF > 450 ms, female QTcF > 470 ms); or other abnormalities deemed clinically significant by the investigator.
- Positive human immunodeficiency virus (HIV) antibody or positive syphilis screening test.
- Any other condition that, in the investigator's opinion, would make the subject unsuitable for participation in this study.
- Participants with Normal Hepatic Function Only:
- History of hepatic impairment, or physical examination and laboratory tests at screening indicating the presence or possible presence of hepatic impairment.
- Positive hepatitis B surface antigen (HBsAg) or positive hepatitis C virus (HCV) antibody test.
- Hepatically-Impaired Participants Only :
- History of drug-induced liver injury (DILI) or prior liver transplantation.
- Acute liver injury due to any cause within 3 months prior to screening.
- History of cholestatic liver disease or biliary obstruction, or other conditions affecting bile excretion, within 3 months prior to screening.
- History of portal hypertension complicated by esophagogastric variceal bleeding within 6 months prior to screening, or portosystemic shunt surgery, including transjugular intrahepatic portosystemic shunt (TIPS), within 6 months prior to screening.
- Severe or late-stage ascites or pleural effusion requiring paracentesis and albumin supplementation, or hepatorenal syndrome.
- Hepatic failure, or complications hepatic encephalopathy or esophagogastric variceal bleeding that, in the investigator's opinion, are unsuitable for participation in this study.
- Major Organ Function:
- Coagulation function: INR > 2.5 without intervention by procoagulant or anticoagulant medications (after a 2-week washout period).
- Hematology: absolute neutrophil count (ANC) < 0.75 × 10⁹/L, hemoglobin < 80 g/L, and platelet count < 30 × 10⁹/L.
- Hepatic function: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 5 × upper limit of normal (ULN).
- Renal function: estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m², calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
About this study
Official title: A Pharmacokinetic Study of JMKX003142 Tablets in Participants With Hepatic Impairment and Participants With Normal Hepatic Function
The primary purpose of this study is to evaluate the plasma PK of JMKX003142 following a single dose in participants with mild and moderate hepatic impairment compared to matched healthy participants with normal hepatic function.
- Being tested
- JMKX003142
- 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.
JMKX003142Drug
Single oral dose of JMKX003142 in participants from all groups
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Participants with mild hepatic impairment Receives: Drug: JMKX003142 |
| Cohort 2 | Experimental | Participants with moderate hepatic impairment Receives: Drug: JMKX003142 |
| Cohort 3 | Experimental | Matched participants with normal hepatic function Receives: Drug: JMKX003142 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameter Cmax
maximum observed plasma concentration
Measured: Predose up to 6 days postdose
PK parameters AUC0-t
area under the curve from time zero to the specified time point
Measured: Predose up to 6 days postdose
PK parameters AUC0-inf
area under the curve from time Zero extrapolated to Infinity
Measured: Predose up to 6 days postdose
PK parameters Cmax, u
unbound maximum plasma concentration
Measured: Predose up to 6 days postdose
PK parameters AUC0-t, u
area under the unbound concentration-time curve from time zero to the specified time point
Measured: Predose up to 6 days postdose
PK parameters AUC0-inf, u
area under the unbound concentration-time curve curve from time Zero extrapolated to Infinity
Measured: Predose up to 6 days postdose
Secondary outcomes (7)
PK parameters tmax
time to reach maximum observed plasma concentration
Measured: Predose up to 6 days postdose
PK Parameters t1/2
terminal phase half-life
Measured: Predose up to 6 days postdose
PK Parameters Vz/F
apparent volume of distribution
Measured: Predose up to 6 days postdose
PK Parameters CL/F
apparent clearance
Measured: Predose up to 6 days postdose
plasma protein binding (PPB) and fraction unbound (fu)
plasma protein binding rate
Measured: Predose up to 6 days postdose
PK Parameters CL/F, u
unbound apparent clearance
Measured: Predose up to 6 days postdose
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
To evaluate the safety and tolerability of a single dose of JMKX003142 in subjects with mild or moderate hepatic impairment, and in healthy subjects with normal hepatic function
Measured: up to 14 days postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start20 Nov 2026 (estimated)
- Primary completion30 May 2027 (estimated)
- Study completion30 Sep 2027 (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.
- More trials run by JemincareThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 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
- NCT07909070
- Sponsor's protocol ID
- JMKX003142-107
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic Study of JMKX003142 Tablets in Participants With Hepatic Impairment and Participants With Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT07909070
- Acronym / sponsor ID
- JMKX003142-107
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- JemincareIndustry (pharma, biotech, devices)
- Collaborators
- Zhejiang Hangyu Pharmaceutical Co., Ltd.
- Study start
- 20 Nov 2026 (estimated)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to evaluate the plasma PK of JMKX003142 following a single dose in participants with mild and moderate hepatic impairment compared to matched healthy participants with normal hepatic function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: JMKX003142Participants with mild hepatic impairment |
| Cohort 2 | Experimental | Drug: JMKX003142Participants with moderate hepatic impairment |
| Cohort 3 | Experimental | Drug: JMKX003142Matched participants with normal hepatic function |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The participant is able to understand the content of this trial and is willing to comply with the policies, procedures, and constraints of the study, and a written informed consent form must be signed by the subject or a legally authorized representative before any study procedure is performed.
- At the time of signing the informed consent form, aged 18 to 75 years (inclusive), with body weight ≥50 kg for males or ≥45 kg for females, and body mass index (BMI) 18.0 to 30.0 kg/m² (inclusive).
- At screening, all examinations (including physical examination, vital signs, complete blood count, urinalysis, blood biochemistry, coagulation function, electrocardiogram, chest X-ray, abdominal ultrasonography, etc.) were judged by the investigator to be suitable for participation in this study.
- Female participants of childbearing potential with a negative pregnancy test result during the screening period or who are non-lactating; participants of childbearing potential with no plans for conception, cryopreservation, or donation of sperm or ova from the time of informed consent signing until 3 months after the last dose, and who agree to use effective contraception.
- Participant with chronic hepatic impairment due to viral hepatitis, alcoholic liver disease, autoimmune hepatitis, or other primary liver diseases.
Key exclusion criteria (32 listed)
- Allergy to the active ingredients and excipients of JMKX003142, or a history of allergy to two or more substances.
- Participant with clinically significant diseases, including but not limited to: circulatory, respiratory, digestive, urinary and reproductive, endocrine, nervous, and other relevant systems, or diseases or conditions that the investigator considers may affect the study results (except for participant who had impaired liver function and its complications).
- Effect of drug absorption (e.g., dysphagia, gastrointestinal resection, ulcerative colitis, symptomatic or inflammatory bowel disease, chronic diarrhea, and intestinal obstruction, among other gastrointestinal diseases).
- Participant with severe active infection, gastrointestinal surgery, or other major surgery within 4 weeks prior to screening.
- Participant with a history of Hemophobia and Fear of needles, unable to draw blood.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JMKX003142Single oral dose of JMKX003142 in participants from all groups | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
PK parameter Cmax
Time frame: Predose up to 6 days postdose
maximum observed plasma concentration
PK parameters AUC0-t
Time frame: Predose up to 6 days postdose
area under the curve from time zero to the specified time point
PK parameters AUC0-inf
Time frame: Predose up to 6 days postdose
area under the curve from time Zero extrapolated to Infinity
PK parameters Cmax, u
Time frame: Predose up to 6 days postdose
unbound maximum plasma concentration
PK parameters AUC0-t, u
Time frame: Predose up to 6 days postdose
area under the unbound concentration-time curve from time zero to the specified time point
PK parameters AUC0-inf, u
Time frame: Predose up to 6 days postdose
area under the unbound concentration-time curve curve from time Zero extrapolated to Infinity
7 secondary outcomes
PK parameters tmax
Time frame: Predose up to 6 days postdose
PK Parameters t1/2
Time frame: Predose up to 6 days postdose
PK Parameters Vz/F
Time frame: Predose up to 6 days postdose
PK Parameters CL/F
Time frame: Predose up to 6 days postdose
plasma protein binding (PPB) and fraction unbound (fu)
Time frame: Predose up to 6 days postdose
PK Parameters CL/F, u
Time frame: Predose up to 6 days postdose
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: up to 14 days postdose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JMKX003142 in people with ADPKD (Autosomal Dominant Polycystic Kidney Disease) and Renal Edema, run by Jemincare.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK parameter Cmax (time frame: Predose up to 6 days postdose). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.