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| Name | Class |
|---|---|
| Zhejiang Hangyu Pharmaceutical Co., Ltd. | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JMKX003142 SAD experimental group | Experimental | 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. |
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| JMKX003142 MAD experimental group | Experimental | 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. |
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| JMKX003142 FE experimental group | Experimental | Participants will receive 2 Sequence regimens, with a washout period between treatments. |
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| Placebo in Cohorts 1 to 7 | Experimental | Participants in Cohorts 1 to 7 will receive single oral dose of matching placebo on Day 1. |
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| Placebo in 3 Cohorts | Experimental | Participants in 3 Cohorts will receive orally once -daily of matching placebo for 7 consecutive days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JMKX003142 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 18 |
| Number of the Adverse Events that are related to the multiple dose treatment from | multiple dose safety | from baseline to Day 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jianping Su | Contact | +86 15162481262 | sujianping@jemincare.com |
| Name | Affiliation | Role |
|---|---|---|
| Xuening li | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | China |
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| JMKX003142 will be administered orally | Drug | oral once |
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| JMKX003142 will be administered orally | Drug | oral once |
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| Placebo in Cohorts 1 to 7 | Drug | oral once |
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| Placebo in 3 Cohorts | Drug | oral once |
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