Trial of JMKX003801 in Healthy Participants

Launched by JEMINCARE · Aug 8, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new medication called JMKX003801 to see if it is safe and how the body processes it in healthy adults. The study is being conducted with participants in China, and it is designed to ensure that neither the participants nor the researchers know who is receiving the actual medication and who is receiving a placebo (a harmless substitute with no active ingredients). The trial will involve giving either single or multiple doses of JMKX003801 to understand its effects better.

To participate, individuals must be healthy adults aged 18 to 45, with a body mass index (BMI) between 19 and 28, and meet certain health criteria. Those with serious health issues, recent medication use, or who are pregnant or breastfeeding are not eligible. Participants can expect to be closely monitored throughout the study to ensure their safety and comfort. This trial is important for understanding how this new drug may work in the future, but it is still in the early stages of testing.

Gender

ALL

Eligibility 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.