Trial of JMKX003801 in Healthy Participants
- Registration Number
- NCT06549309
- Lead Sponsor
- Jemincare
- 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 Chinese Healthy Adult Participants
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 70
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental JMKX003801 JMKX003801 Placebo Comparator Placebo Normal saline
- Primary Outcome Measures
Name Time Method Adverse events (AEs) From baseline to Day 3 Incidence and features of AEs
- Secondary Outcome Measures
Name Time Method Serum concentrations of JMKX003801 From baseline to Day 3 Serum concentrations of JMKX003801
Trial Locations
- Locations (1)
Huashan Hospital Fudan University
🇨🇳Shanghai, Shanghai, China