Testing the safety and tolerability of JMKX003142 tablets
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
This study is testing if JMKX003142 tablets are safe and how well they are tolerated by healthy adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 106 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Jemincare Industry-sponsored |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT06079541 on ClinicalTrials.gov |
What this trial studies
This Phase 1 clinical study evaluates the safety, tolerability, and pharmacokinetics of JMKX003142 tablets in healthy adult participants. The study employs a randomized, double-blind, placebo-controlled design, administering the drug both as a single dose and multiple doses. Additionally, it examines the effects of food on the drug's absorption through a crossover design. Participants will undergo thorough health assessments to ensure they meet the study's eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates are healthy males and females aged 18-45 who can provide informed consent and meet specific health criteria.
Not a fit: Patients with serious clinical diseases or those who have participated in other clinical studies within the last three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the safety and tolerability of JMKX003142, paving the way for its potential use in treating various conditions.
How similar studies have performed: While this approach is common in early-phase drug testing, the specific drug JMKX003142 has not been previously tested in this manner.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Shanghai, Shanghai
- Zhongshan Hospital, Fudan University — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Xuening li — Fudan University
- Study coordinator: jianping Su
- Email: sujianping@jemincare.com
- Phone: +86 15162481262
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.