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Phase 1 Clinical Study of JMKX003142 Tablets

Sponsor
Jemincare (Industry)
Overall Status
Recruiting
CT.gov ID
NCT06079541
Collaborator
Zhejiang Hangyu Pharmaceutical Co., Ltd (Other)
106
Enrollment
1
Location
5
Arms
20.8
Anticipated Duration (Months)
5.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Drug: JMKX003142 will be administered orally
  • Drug: JMKX003142 will be administered orally
  • Drug: JMKX003142 will be administered orally
  • Drug: Placebo in Cohorts 1 to 7
  • Drug: Placebo in 3 Cohorts
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
106 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
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
Actual Study Start Date :
Jul 6, 2023
Anticipated Primary Completion Date :
Jul 31, 2024
Anticipated Study Completion Date :
Mar 30, 2025

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of the Adverse Events that are related to the single dose treatment [from baseline to Day 18]

      single dose safety

    2. Number of the Adverse Events that are related to the multiple dose treatment from [from baseline to Day 24]

      multiple dose safety

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhongshan Hospital, Fudan University Shanghai Shanghai China

    Sponsors and Collaborators

    • Jemincare
    • Zhejiang Hangyu Pharmaceutical Co., Ltd

    Investigators

    • Principal Investigator: Xuening li, Fudan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jemincare
    ClinicalTrials.gov Identifier:
    NCT06079541
    Other Study ID Numbers:
    • JY-JM-035-101
    First Posted:
    Oct 12, 2023
    Last Update Posted:
    Oct 17, 2023
    Last Verified:
    Jul 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Oct 17, 2023