Mass Balance and Absolute Bioavailability Study of JMKX003142 In Healthy Volunteers

NCT07463053 | Not Yet Recruiting Phase 1

• 1 other identifier: JMKX003142-105
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief 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 bioavailability using JMKX003142 and radiolabelled JMKX003142 as intravenous and oral forms

Conditions

ADPKD (Autosomal Dominant Polycystic Kidney Disease)

Outcome Measures

Primary Outcomes (2)

• 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)

  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

  96 hours

Secondary Outcomes (5)

• Part1: Maximum Concentration (Cmax) of JMKX003142 in Plasma

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

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

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

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

  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

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

• Frequency and severity of Participants With Adverse Events (AEs)

  Up to Day 30

Study Arms (2)

Part1: Mass Balance

EXPERIMENTAL

Participants will receive oral \[14C\] JMKX003142 under fasted conditions

Drug: [14C]JMKX003142

Part2: Absolute Bioavailability

EXPERIMENTAL

Participants will receive oral JMKX003142 under fasted conditions, followed by intravenous IV \[14C\]

Drug: JMKX003142 tablets; Drug: [14C]JMKX003142 solution for infusion

Interventions

[14C]JMKX003142 DRUG

Participants will receive oral \[14C\]JMKX003142

Part1: Mass Balance

JMKX003142 tablets DRUG

Participants will receive oral JMKX003142

Part2: Absolute Bioavailability

[14C]JMKX003142 solution for infusion DRUG

Participants will receive IV \[14C\] JMKX003142

Part2: Absolute Bioavailability

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jemincare: lead
• Zhejiang Hangyu Pharmaceutical Co., Ltd.: collaborator

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 10, 2026
• Study Start: March 18, 2026
• Primary Completion: May 7, 2026
• Study Completion: June 11, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03