Phase 1 Clinical Study of JMKX003142 Tablets

October 13, 2023 updated by: Jemincare

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

106

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Zhongshan Hospital, Fudan University
        • Contact:
          • Xuening Li

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Male and female subjects aged 18-45 years (including boundary values)
  2. Able to sign a written informed consent form
  3. Physical examination, clinical laboratory examination value, Virology examination, vital signs and 12 lead ECG examination are confirmed by the researcher to be normal or abnormal without clinical significance
  4. The subjects have a thorough understanding of the study content, process, and potential adverse effects, and are willing to complete the study according to the requirements of the experimental protocol

Exclusion Criteria:

  1. Had or currently have serious clinical diseases related to circulatory system, respiratory system, digestive system, nervous system, endocrine system, blood lymphatic system, genitourinary system or psychiatry, as well as habitual constipation, gastrointestinal bleeding history, which is judged to be inappropriate for the study by the investigators
  2. Participants in any other clinical study within 3 months prior to the first administration of this study
  3. The investigators believe that the subject has other factors that are not suitable for participating in this experiment
  4. Pregnant or lactating women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: JMKX003142 SAD experimental group
Participants will be randomized into 7 cohorts to receive single oral dose of JMKX003142 on Day 1. The doses in each cohort will be escalated based on the safety and pharmacokinetics (PK) / Pharmacodynamics (PD) data of the previous cohort.
Drug: JMKX003142 will be administered orally
oral once
Other Names:
  • JMKX003142
Experimental: JMKX003142 MAD experimental group
Participants will be randomized into 3 cohorts to receive orally once -daily of JMKX003142 for 7 consecutive days. The second cohort will be escalated based on the safety and pharmacokinetics (PK)/ Pharmacodynamics (PD) data of the previous cohort.
Drug: JMKX003142 will be administered orally
oral once
Other Names:
  • JMKX003142
Experimental: JMKX003142 FE experimental group
Participants will receive 2 Sequence regimens, with a washout period between treatments.
Drug: JMKX003142 will be administered orally
oral once
Other Names:
  • JMKX003142
Experimental: Placebo in Cohorts 1 to 7
Participants in Cohorts 1 to 7 will receive single oral dose of matching placebo on Day 1.
Drug: Placebo in Cohorts 1 to 7
oral once
Other Names:
  • Matching placebo will be administered orally
Experimental: Placebo in 3 Cohorts
Participants in 3 Cohorts will receive orally once -daily of matching placebo for 7 consecutive days.
Drug: Placebo in 3 Cohorts
oral once
Other Names:
  • Matching placebo will be administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of the Adverse Events that are related to the single dose treatment
Time Frame: from baseline to Day 18
single dose safety
from baseline to Day 18
Number of the Adverse Events that are related to the multiple dose treatment from
Time Frame: from baseline to Day 24
multiple dose safety
from baseline to Day 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jemincare

Collaborators

Zhejiang Hangyu Pharmaceutical Co., Ltd

Investigators

  • Principal Investigator: Xuening li, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 6, 2023

Primary Completion (Estimated)

July 31, 2024

Study Completion (Estimated)

March 30, 2025

Study Registration Dates

First Submitted

October 6, 2023

First Submitted That Met QC Criteria

October 6, 2023

First Posted (Actual)

October 12, 2023

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

October 13, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • JY-JM-035-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Safety and Tolerability

Clinical Trials on JMKX003142 will be administered orally

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe