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Healthy men to help unravel how new kidney drug is processed

NCT ID NCT07463053

Knowledge-focused Sponsor: Jemincare Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 1 trial will enroll 8 healthy Chinese men to study how the experimental drug JMKX003142 is absorbed, broken down, and eliminated from the body. Participants will receive the drug in both pill and IV forms, some with a radioactive tracer. The study aims to measure the drug's bioavailability and how much is excreted in urine and stool. No treatment benefit is expected, as this is purely a research study to guide future dosing in patients with polycystic kidney disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
JMKX003142 (a drug being developed for polycystic kidney disease)
What this could lead to
If successful, this study will help determine the right dose and how the drug is cleared from the body, supporting future trials in patients with polycystic kidney disease.
What could go wrong
This is a very early, small study in healthy volunteers, not patients. It is designed to gather basic information, not to test if the drug works. The drug may still fail in later trials.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 8 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Chinese healthy males. 2. The age between 18 and 45 years (extremes included), on the date of signing the informed consent form (ICF). 3. Body mass index (BMI) range of 19-26.0 kg/m² (inclusive of boundary values), with body weight not less than 55.0 kg. Exclusion Criteria: 1. 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). 2. White blood cell count and/or hemoglobin below the lower limit of the normal range in complete blood count. 3. Resting corrected QT interval (QTcF) \>450 ms (corrected by Fridericia's formula, QTcF = QT/RR\^1/3). 4. Hepatitis B surface antigen or E antigen positive, anti-HCV IgG positive, syphilis treponemal antibody positive, and HIV antigen/antibody combination test positive. 5. 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.

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Conditions

The condition(s) this trial relates to.

autosomal dominant polycystic kidney disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adpkd (autosomal dominant polycystic kidney disease)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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