Healthy
Conditions
Keywords
Safety, Tolerability, Pharmacokinetics
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
Interventions
DRUGJMKX003801
For 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.
DRUGPlacebo
For 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.
Sponsors
Jemincare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events (AEs) | From baseline to Day 3 | Incidence and features of AEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum concentrations of JMKX003801 | From baseline to Day 3 | Serum concentrations of JMKX003801 |
Countries
China
Contacts
Primary ContactHongzhang Ji
Outcome results
None listed