Status:
UNKNOWN
Phase 1 Clinical Study of JMKX003142 Tablets
Lead Sponsor:
Jemincare
Collaborating Sponsors:
Zhejiang Hangyu Pharmaceutical Co., Ltd.
Conditions:
Safety and Tolerability
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2025
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT06079541
Start Date
July 6 2023
End Date
March 30 2025
Last Update
October 17 2023
Active Locations (1)
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1
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China