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

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 Overview

• Status: Not yet recruiting
• Conditions: ADPKD (Autosomal Dominant Polycystic Kidney Disease)
• Intervention / Treatment: Drug: [14C]JMKX003142; Drug: JMKX003142 tablets; Drug: [14C]JMKX003142 solution for infusion

• Study Type: Interventional
• Enrollment (Estimated): 8
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part1: Mass Balance; Participants will receive oral [14C] JMKX003142 under fasted conditions	Drug: [14C]JMKX003142; Participants will receive oral [14C]JMKX003142
Experimental: Part2: Absolute Bioavailability; Participants will receive oral JMKX003142 under fasted conditions, followed by intravenous IV [14C]	Drug: JMKX003142 tablets; Participants will receive oral JMKX003142; Drug: [14C]JMKX003142 solution for infusion; Participants will receive IV [14C] JMKX003142

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Jemincare
• Collaborators: Zhejiang Hangyu Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): March 18, 2026
• Primary Completion (Estimated): May 7, 2026
• Study Completion (Estimated): June 11, 2026

Study Registration Dates

• First Submitted: March 2, 2026
• First Submitted That Met QC Criteria: March 6, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ciliopathies; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genetic Diseases, Inborn; Congenital Abnormalities; Abnormalities, Multiple; Kidney Diseases, Cystic; Polycystic Kidney Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Polycystic Kidney, Autosomal Dominant
• Other Study ID Numbers: JMKX003142-105

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No