Fact CheckerSign in

NCT07463053Not yet recruitingPhase 1

Mass Balance and Absolute Bioavailability Study of JMKX003142 In Healthy Volunteers

A Study to Evaluate the Mass Balance and Absolute Bioavailability of [14C]JMKX003142 in Healthy Male Participants

Source: ClinicalTrials.gov · Last updated 10 Mar 2026

Brief summary (registry, in English)

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

Status (registry)
Not yet recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
8 (estimated)
First submitted
2 Mar 2026
Start date
18 Mar 2026
Primary completion date
7 May 2026
Lead sponsor
Jemincare
NCT number
NCT07463053

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 8
  • From 18 Mar 2026 to the primary completion date, 7 May 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • Hepatitis B surface antigen or E antigen positive, anti-HCV IgG positive, syphilis treponemal antibody positive, and HIV antigen/antibody combination test positive.

Lab values

  • 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).

Who the study is looking for

  • 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.

Age in the registry: 18 years to 45 years · Sex: Male · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.