Trial of JMKX003801 in Healthy Participants
ConditionHealthy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorJemincare
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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) .
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
JMKX003801
DrugFor Ascending Single Dose of JMKX003801，Five（5）cohorts of 40 participants (each cohort contains 6 active and 2 placebo) are planned for evaluation. For Ascending Multiple Dose of JMKX003801，Three（3）cohort of 30 participants (each cohort contains 8 active and 2 placebo) are planned for evaluation.
Placebo
DrugFor Ascending Single Dose of JMKX003801，Five（5）cohorts of 40 participants (each cohort contains 6 active and 2 placebo) are planned for evaluation. For Ascending Multiple Dose of JMKX003801，Three（3）cohorts of 30 participants (each cohort contains 8 active and 2 placebo) are planned for evaluation.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: ExperimentalActive comparator 1 intervention
Group B: Placebo ComparatorPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Adverse events (AEs)
Incidence and features of AEs
Time frame
From baseline to Day 3Secondary outcomes
1
Serum concentrations of JMKX003801
Serum concentrations of JMKX003801
Time frame
From baseline to Day 3 Source ClinicalTrials.gov