ADPKD (Autosomal Dominant Polycystic Kidney Disease)Phase 1NCT07463053
Mass Balance and Absolute Bioavailability Study of JMKX003142 In Healthy Volunteers
A Phase 1 study testing [14C]JMKX003142, JMKX003142 tablets and [14C]JMKX003142 solution for infusion in people with ADPKD (Autosomal Dominant Polycystic Kidney Disease), run by Jemincare.
Trial summary
A phase 1 healthy volunteer study to assess the excretion and metabolism as well as the absolute bioavailability of oral JMKX003142. The study will be conducted in two parts: Part 1 to assess the mass balance of JMKX003142 using orally administered radiolabelled JMKX003142; part 2 will assess the absolute… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- ADPKD (Autosomal Dominant Polycystic Kidney Disease)
- What is being tested?
- [14C]JMKX003142, JMKX003142 tablets and [14C]JMKX003142 solution for infusion
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 18 Mar 2026to 11 Jun 2026
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Chinese healthy males.
- The age between 18 and 45 years (extremes included), on the date of signing the informed consent form (ICF).
- Body mass index (BMI) range of 19-26.0 kg/m² (inclusive of boundary values), with body weight not less than 55.0 kg.
Who cannot join
- Abnormal findings with clinical significance on comprehensive physical examination, vital signs, digital rectal examination, laboratory tests (complete blood count, blood biochemistry, coagulation function, urinalysis, fecal routine with occult blood, thyroid function), ophthalmological examination, 12-lead electrocardiogram, chest X-ray (posteroanterior view), and abdominal ultrasound (liver, gallbladder, pancreas, spleen, kidneys).
- White blood cell count and/or hemoglobin below the lower limit of the normal range in complete blood count.
- Resting corrected QT interval (QTcF) >450 ms (corrected by Fridericia's formula, QTcF = QT/RR^1/3).
- Hepatitis B surface antigen or E antigen positive, anti-HCV IgG positive, syphilis treponemal antibody positive, and HIV antigen/antibody combination test positive.
- Subjects with gastrointestinal diseases causing clinically significant symptoms such as nausea, vomiting, diarrhea, or malabsorption syndrome, or those with a history of severe vomiting or diarrhea within one week prior to screening.
About this study
Official title: A Study to Evaluate the Mass Balance and Absolute Bioavailability of [14C]JMKX003142 in Healthy Male Participants
A phase 1 healthy volunteer study to assess the excretion and metabolism as well as the absolute bioavailability of oral JMKX003142. The study will be conducted in two parts: Part 1 to assess the mass balance of JMKX003142 using orally administered radiolabelled JMKX003142; part 2 will assess the absolute bioavailability using JMKX003142 and radiolabelled JMKX003142 as intravenous and oral forms
- Being tested
- [14C]JMKX003142, JMKX003142 tablets, [14C]JMKX003142 solution for infusion
- 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.
[14C]JMKX003142Drug
Participants will receive oral [14C]JMKX003142
JMKX003142 tabletsDrug
Participants will receive oral JMKX003142
[14C]JMKX003142 solution for infusionDrug
Participants will receive IV [14C] JMKX003142
| Study group | Role | What they receive |
|---|---|---|
| Part1: Mass Balance | Experimental | Participants will receive oral [14C] JMKX003142 under fasted conditions Receives: Drug: [14C]JMKX003142 |
| Part2: Absolute Bioavailability | Experimental | Participants will receive oral JMKX003142 under fasted conditions, followed by intravenous IV [14C] Receives: Drug: JMKX003142 tablets; Drug: [14C]JMKX003142 solution for infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mass balance of JMKX003142
Total recovery of radioactivity in urine and faeces following a single oral dose of [14C]-JMKX003142 (expressed as a percentage of the total radioactive dose administered)
Measured: up to 15 days (until >90% of dose is recovered)
Absolute bioavailability of JMKX003142 in plasma
Absolute bioavailability is calculated from the AUCs of iv and oral administration
Measured: 96 hours
Secondary outcomes (5)
Part1: Maximum Concentration (Cmax) of JMKX003142 in Plasma
Measured: Day 1 to day 15 (depending on recovery of dose)
Part1: Time to Reach Maximum Concentration (tmax) of JMKX003142 in Plasma
Measured: Day 1 to day 15 (depending on recovery of dose)
Part1: Apparent Terminal Half-Life (t1/2) Of JMKX003142
Measured: Day 1 to day 15 (depending on recovery of dose)
Part1: Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC0-inf) of JMKX003142 in Plasma
Measured: Day 1 to day 15 (depending on recovery of dose)
Frequency and severity of Participants With Adverse Events (AEs)
Measured: Up to Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start18 Mar 2026 (estimated)
- Primary completion7 May 2026 (estimated)
- Study completion11 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.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 8 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
- NCT07463053
- Sponsor's protocol ID
- JMKX003142-105
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 10 Mar 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 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Mass Balance and Absolute Bioavailability of [14C]JMKX003142 in Healthy Male Participants
- ClinicalTrials.gov ID
- NCT07463053
- Acronym / sponsor ID
- JMKX003142-105
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- JemincareIndustry (pharma, biotech, devices)
- Collaborators
- Zhejiang Hangyu Pharmaceutical Co., Ltd.
- Study start
- 18 Mar 2026 (estimated)
- Primary completion
- 7 May 2026 (estimated)
- Study completion
- 11 Jun 2026 (estimated)
- First posted
- 10 Mar 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.
A phase 1 healthy volunteer study to assess the excretion and metabolism as well as the absolute bioavailability of oral JMKX003142. The study will be conducted in two parts: Part 1 to assess the mass balance of JMKX003142 using orally administered radiolabelled JMKX003142; part 2 will assess the absolute bioavailability using JMKX003142 and radiolabelled JMKX003142 as intravenous and oral forms
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part1: Mass Balance | Experimental | Drug: [14C]JMKX003142Participants will receive oral [14C] JMKX003142 under fasted conditions |
| Part2: Absolute Bioavailability | Experimental | Drug: JMKX003142 tablets, Drug: [14C]JMKX003142 solution for infusionParticipants will receive oral JMKX003142 under fasted conditions, followed by intravenous IV [14C] |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Chinese healthy males.
- The age between 18 and 45 years (extremes included), on the date of signing the informed consent form (ICF).
- Body mass index (BMI) range of 19-26.0 kg/m² (inclusive of boundary values), with body weight not less than 55.0 kg.
Key exclusion criteria (5 listed)
- Abnormal findings with clinical significance on comprehensive physical examination, vital signs, digital rectal examination, laboratory tests (complete blood count, blood biochemistry, coagulation function, urinalysis, fecal routine with occult blood, thyroid function), ophthalmological examination, 12-lead electrocardiogram, chest X-ray (posteroanterior view), and abdominal ultrasound (liver, gallbladder, pancreas, spleen, kidneys).
- White blood cell count and/or hemoglobin below the lower limit of the normal range in complete blood count.
- Resting corrected QT interval (QTcF) >450 ms (corrected by Fridericia's formula, QTcF = QT/RR^1/3).
- Hepatitis B surface antigen or E antigen positive, anti-HCV IgG positive, syphilis treponemal antibody positive, and HIV antigen/antibody combination test positive.
- Subjects with gastrointestinal diseases causing clinically significant symptoms such as nausea, vomiting, diarrhea, or malabsorption syndrome, or those with a history of severe vomiting or diarrhea within one week prior to screening.
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 |
|---|---|---|
| [14C]JMKX003142Participants will receive oral [14C]JMKX003142 | Drug | Part1: Mass Balance |
| JMKX003142 tabletsParticipants will receive oral JMKX003142 | Drug | Part2: Absolute Bioavailability |
| [14C]JMKX003142 solution for infusionParticipants will receive IV [14C] JMKX003142 | Drug | Part2: Absolute Bioavailability |
Primary outcome
Mass balance of JMKX003142
Time frame: up to 15 days (until >90% of dose is recovered)
Total recovery of radioactivity in urine and faeces following a single oral dose of [14C]-JMKX003142 (expressed as a percentage of the total radioactive dose administered)
Absolute bioavailability of JMKX003142 in plasma
Time frame: 96 hours
Absolute bioavailability is calculated from the AUCs of iv and oral administration
5 secondary outcomes
Part1: Maximum Concentration (Cmax) of JMKX003142 in Plasma
Time frame: Day 1 to day 15 (depending on recovery of dose)
Part1: Time to Reach Maximum Concentration (tmax) of JMKX003142 in Plasma
Time frame: Day 1 to day 15 (depending on recovery of dose)
Part1: Apparent Terminal Half-Life (t1/2) Of JMKX003142
Time frame: Day 1 to day 15 (depending on recovery of dose)
Part1: Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC0-inf) of JMKX003142 in Plasma
Time frame: Day 1 to day 15 (depending on recovery of dose)
Frequency and severity of Participants With Adverse Events (AEs)
Time frame: Up to Day 30
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 10 Mar 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 [14C]JMKX003142, JMKX003142 tablets and [14C]JMKX003142 solution for infusion in people with ADPKD (Autosomal Dominant Polycystic Kidney Disease), 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 3 inclusion and 5 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 10 Mar 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?
Mass balance of JMKX003142 (time frame: up to 15 days (until >90% of dose is recovered)). The study lists 2 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 10 Mar 2026.