Phase 1 Clinical Study of JMKX003142 Tablets

NCT06079541 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2023-10-17

No results posted yet for this study

Summary

Phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of JMKX003142 tablets administered randomly, double-blind, placebo-controlled single and multiple times in healthy adult subjects, as well as the effects of randomized, open, and two cycle crossover foods

Conditions

  • Safety and Tolerability

Interventions

DRUG

JMKX003142 will be administered orally

oral once

DRUG

JMKX003142 will be administered orally

oral once

DRUG

JMKX003142 will be administered orally

oral once

DRUG

Placebo in Cohorts 1 to 7

oral once

DRUG

Placebo in 3 Cohorts

oral once

Sponsors & Collaborators

  • Zhejiang Hangyu Pharmaceutical Co., Ltd.

    collaborator INDUSTRY
  • Jemincare

    lead INDUSTRY

Principal Investigators

  • Xuening li · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-07-06
Primary Completion
2024-07-31
Completion
2025-03-30

Countries

  • China

Study Locations

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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 NCT06079541 on ClinicalTrials.gov