Evaluating JMKX003801 in Healthy Adults
A Phase I, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics of JMKX003801 in Healthy Participants
This study is testing a new drug called JMKX003801 in healthy adults to see how it works in the body and if it has any side effects.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Jemincare Industry-sponsored |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06549309 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the safety, tolerability, and pharmacokinetics of JMKX003801 in healthy adult participants. It employs a randomized, double-blind, placebo-controlled design with both single-ascending and multiple-ascending doses. The study aims to gather data on how the drug behaves in the body and its potential side effects. Participants will be closely monitored throughout the trial to ensure their safety and adherence to the protocol.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 to 45 with a BMI between 19 and 28.
Not a fit: Patients with serious clinical diseases or those taking medications that could interfere with the study results will not benefit from this trial.
Why it matters
Potential benefit: If successful, this study could provide valuable information on the safety and dosing of JMKX003801 for future therapeutic applications.
How similar studies have performed: Other studies have shown success in evaluating the safety and pharmacokinetics of new drugs in healthy populations, making this approach well-established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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; * Healthy adult males and/or females, 18 to 45 years of age; * Body mass index (BMI) ≥ 19 and ≤ 28.0 (kg/m2) ,weight ≥45kg (female) or ≥50kg (male) . Exclusion Criteria: * 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, or any other diseases judged by investigators that will be interference to the results of this study; * Use of any over-the-counter (OTC) medication, prescription medicine, Chinese herbal medicine , within 2 weeks prior to the time of informed consent signed; * Pregnant or lactating women; * Other conditions unsuitable for the trial judged by the investigators.
Where this trial is running
Shanghai, Shanghai Municipality
- Huashan Hospital Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Jing Zhang — Huashan Hospital
- Study coordinator: Hongzhang Ji
- Email: jihongzhang@jemincare.com
- Phone: +8618261053520
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.