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Mass Balance and Absolute Bioavailability Study of JMKX003142 In Healthy Volunteers

NCT07463053 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2026-03-10

No results posted yet for this study

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)

Interventions

DRUG

[14C]JMKX003142

Participants will receive oral \[14C\]JMKX003142

DRUG

JMKX003142 tablets

Participants will receive oral JMKX003142

DRUG

[14C]JMKX003142 solution for infusion

Participants will receive IV \[14C\] JMKX003142

Sponsors & Collaborators

  • Zhejiang Hangyu Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Jemincare

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-18
Primary Completion
2026-05-07
Completion
2026-06-11

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07463053 on ClinicalTrials.gov