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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
Pharmacokinetic (PK) parameters, Pharmacodynamics
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JMKX003002 SAD experimental group | Experimental | 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. |
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| JMKX003002 MAD experimental group | Experimental | 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. |
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| JMKX003002 FE experimental group | Experimental | Participants will receive 3 Sequence regimens, with a washout period between treatments. |
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| Placebo in Cohorts 1 to 5 | Placebo Comparator | Participants in Cohorts 1 to 5 will receive single oral dose of matching placebo on Day 1. |
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| Placebo in 2 Cohorts | Placebo Comparator | Participants in 2 Cohorts will receive orally twice -daily of matching placebo for 7 consecutive days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JMKX003002 will be administered orally | Drug | oral once |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Xu | Contact | 021-52887926 | xujing2@jimincare.com |
| Name | Affiliation | Role |
|---|---|---|
| Jing Zhang | Huashan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital Fudan University | Recruiting | Shanghai | Shanghai Municipality | China |
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| JMKX003002 will be administered orally | Drug | oral once |
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| JMKX003002 will be administered orally | Drug | oral once |
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| Placebo in Cohorts 1 to 5 | Drug | oral once |
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| Placebo in 2 Cohorts | Drug | oral once |
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