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The purpose of this study is to investigate the safety, tolerability and pharmacokinetic characteristics of JX11502MA capsule on healthy human, and to explore the relationship between the dose, pharmacokinetic parameters and safety of JX11502MA capsule,so as to provide basis for the follow-up clinical trials (multi-dose tolerability, pharmacokinetics and phase II trial, etc.).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JX11502MA 0.25mg、0.5mg、1mg、2mg、3mg、6mg、8mg | Experimental | Participants received JX11502MA capsule 0.25mg、0.5mg、1mg、2mg、3mg、6mg、8mg orally administration once, once on an empty stomach in the morning, with about 240ml of warm water. |
|
| Placebo 0.25mg、0.5mg、1mg、2mg、3mg、6mg、8mg | Placebo Comparator | Participants received placebo capsule 0.25mg、0.5mg、1mg、2mg、3mg、6mg、8mg orally administration once, once on an empty stomach in the morning, with about 240ml of warm water.. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JX11502MA | Drug | Oral capsule |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence rate of adverse reactions | Count the number of subjects with adverse reactions during the trial and calculate the incidence of adverse reactions(Number of subjects with adverse reactions / total number of subjects* 100%).The adverse reactions include drowsiness、weakness hiccup、vomit、anorexia、nausea、insomnia、dry mouth、dizzy and stomach distention | Day(1)-Day(7) |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum Serum Concentration of the parent drug | Day(1)-Day(7) |
| Tmax | Time to Reach the Maximum Serum Concentration of the parent drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huafang Li, Doctor | Contact | (86)021-34773128 | lhlh_5@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Mental Health Center | Recruiting | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38054696 | Derived | Yu Y, He J, Huang Z, Li Y, Wu Y, Shen Y, Zhou Y, Bao C, Jin Z, Li H. Safety, tolerability, and pharmacokinetics of JX11502MA in Chinese healthy subjects: a first-in-human, randomized, double-blind, placebo-controlled study following single-dose administration. Expert Opin Investig Drugs. 2024 Jan;33(1):51-61. doi: 10.1080/13543784.2023.2291470. Epub 2024 Feb 12. |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| Placebo |
| Drug |
Oral capsule |
|
| Day(1)-Day(7) |
| AUC | Area Under the Serum Concentration-Time Curve of the parent drug | Day(1)-Day(7) |
| t1/2 | Elimination half-life period | Day(1)-Day(7) |