Safety and Tolerability
Conditions
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 in healthy adult subjects, as well as the effects of randomized, open, and two cycle crossover foods
Interventions
oral once
DRUGPlacebo in Cohorts 1 to 7
oral once
DRUGPlacebo in 3 Cohorts
oral once
Sponsors
Zhejiang Hangyu Pharmaceutical Co., Ltd.
Jemincare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male and female subjects aged 18-45 years (including boundary values) 2. Able to sign a written informed consent form 3. 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 4. 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 criteria
1. 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 2. Participants in any other clinical study within 3 months prior to the first administration of this study 3. The investigators believe that the subject has other factors that are not suitable for participating in this experiment 4. Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of the Adverse Events that are related to the single dose treatment | from baseline to Day 18 | single dose safety |
| Number of the Adverse Events that are related to the multiple dose treatment from | from baseline to Day 24 | multiple dose safety |
Countries
China
Contacts
Primary Contactjianping Su
Outcome results
None listed