Safety, Tolerability of JMKX003002 in Phase 1 Study in Healthy Subjects

Study Overview
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Brief Summary
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Safety, tolerability, pharmacokinetics, and pharmacodynamics of JMKX003002 in single and multiple ascending dose randomized，doubled-blind phase 1 study in healthy subjects

Detailed Description
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Pharmacokinetic (PK) parameters, Pharmacodynamics

Official Title
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Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JMKX003002 in Single and Multiple Ascending Dose Randomized，Doubled-blind Phase 1 Study in Healthy Subjects

Conditions
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Safety and Tolerability

Intervention / Treatment
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* Drug: JMKX003002 will be administered orally
* Drug: JMKX003002 will be administered orally
* Drug: JMKX003002 will be administered orally
* Drug: Placebo in Cohorts 1 to 5
* Drug: Placebo in 2 Cohorts


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects aged 18-45 years (inclusive);- With normal or abnormal but clinically insignificant comprehensive physical examination (vital signs, physical examination), laboratory tests (hematology, blood biochemistry, urinalysis, coagulation function test) and, 12-lead ECG; Subjects who understand study procedures and methods, voluntarily participate in this trial, follow study-related instructions, and sign a written informed consent form. Exclusion Criteria: Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematologic, metabolic, endocrine, neurologic, psychiatric disease, or any condition that may interfere with the subject successfully completing the trial Subjects with history of or current malignancy; Participant who the researchers believe that there are volunteers who are not suitable for

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: JMKX003002 SAD experimental group<br>Participants will be randomized into 5 cohorts to receive single oral dose of JMKX003002 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: JMKX003002 will be administered orally<br>* oral once<br>* Other names: JMKX003002;|
| Experimental: JMKX003002 MAD experimental group<br>Participants will be randomized into 2 cohorts to receive orally twice -daily of JMKX003002 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: JMKX003002 will be administered orally<br>* oral once<br>* Other names: JMKX003002;|
| Experimental: JMKX003002 FE experimental group<br>Participants will receive 3 Sequence regimens, with a washout period between treatments. | Drug: JMKX003002 will be administered orally<br>* oral once<br>* Other names: JMKX003002;|
| Placebo Comparator: Placebo in Cohorts 1 to 5<br>Participants in Cohorts 1 to 5 will receive single oral dose of matching placebo on Day 1. | Drug: Placebo in Cohorts 1 to 5<br>* oral once<br>* Other names: Matching placebo will be administered orally;|
| Placebo Comparator: Placebo in 2 Cohorts<br>Participants in 2 Cohorts will receive orally twice -daily of matching placebo for 7 consecutive days. | Drug: Placebo in 2 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 11 | 
| Number of the Adverse Events that are related to the multiple dose treatment from baseline to Day 18 | multiple dose safety | from baseline to Day 18 |