Phase 1 Clinical Study of JMKX003142 Tablets

Study Overview
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Brief Summary
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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

Official Title
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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
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Safety and Tolerability

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female subjects aged 18-45 years (including boundary values) Able to sign a written informed consent form 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 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: 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 Participants in any other clinical study within 3 months prior to the first administration of this study The investigators believe that the subject has other factors that are not suitable for participating in this experiment Pregnant or lactating women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JMKX003142 SAD experimental group<br>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<br>* oral once<br>* Other names: JMKX003142;|
| Experimental: JMKX003142 MAD experimental group<br>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<br>* oral once<br>* Other names: JMKX003142;|
| Experimental: JMKX003142 FE experimental group<br>Participants will receive 2 Sequence regimens, with a washout period between treatments. | Drug: JMKX003142 will be administered orally<br>* oral once<br>* Other names: JMKX003142;|
| Experimental: Placebo in Cohorts 1 to 7<br>Participants in Cohorts 1 to 7 will receive single oral dose of matching placebo on Day 1. | Drug: Placebo in Cohorts 1 to 7<br>* oral once<br>* Other names: Matching placebo will be administered orally;|
| Experimental: Placebo in 3 Cohorts<br>Participants in 3 Cohorts will receive orally once -daily of matching placebo for 7 consecutive days. | Drug: Placebo in 3 Cohorts<br>* oral once<br>* Other names: Matching placebo will be administered orally;|

What is the study measuring?
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Primary Outcome Measures

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