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NCT Number: NCT07463053

Mass Balance and Absolute Bioavailability Study of JMKX003142 In Healthy Volunteers

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

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

[14C]JMKX003142

Drug

Participants will receive oral [14C]JMKX003142

JMKX003142 tablets

Drug

Participants will receive oral JMKX003142

[14C]JMKX003142 solution for infusion

Drug

Participants will receive IV [14C] JMKX003142

Primary outcomes

  1. 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)

  2. Absolute bioavailability of JMKX003142 in plasma

    Time frame: 96 hours

    Absolute bioavailability is calculated from the AUCs of iv and oral administration

Secondary outcomes

  1. Part1: Maximum Concentration (Cmax) of JMKX003142 in Plasma

    Time frame: Day 1 to day 15 (depending on recovery of dose)

  2. Part1: Time to Reach Maximum Concentration (tmax) of JMKX003142 in Plasma

    Time frame: Day 1 to day 15 (depending on recovery of dose)

  3. Part1: Apparent Terminal Half-Life (t1/2) Of JMKX003142

    Time frame: Day 1 to day 15 (depending on recovery of dose)

  4. 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)

  5. Frequency and severity of Participants With Adverse Events (AEs)

    Time frame: Up to Day 30

Sponsors and collaborators

Lead sponsor

Jemincare

Industry

Collaborators

  • Zhejiang Hangyu Pharmaceutical Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 10, 2026
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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