Status:
RECRUITING
Trial of JMKX003801 in Healthy Participants
Lead Sponsor:
Jemincare
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
To Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of JMKX003801 Administered Randomly, Double-blind, Placebo-controlled, Single-ascending Dose and Multiple-ascending Dose in Ch...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 12 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06549309
Start Date
August 17 2024
End Date
June 12 2025
Last Update
September 26 2024
Active Locations (1)
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1
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, China