Safety and Tolerability
Conditions
Brief summary
Safety, tolerability, pharmacokinetics, and pharmacodynamics of JMKX003002 in single and multiple ascending dose randomized，doubled-blind phase 1 study in healthy subjects
Detailed description
Pharmacokinetic (PK) parameters, Pharmacodynamics
Interventions
oral once
DRUGPlacebo in Cohorts 1 to 5
oral once
DRUGPlacebo in 2 Cohorts
oral once
Sponsors
Jemincare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female subjects aged 18-45 years (inclusive);- 2. With normal or abnormal but clinically insignificant comprehensive physical examination (vital signs, physical examination), laboratory tests (hematology, blood biochemistry, urinalysis, coagulation function test) and, 12-lead ECG; 3. Subjects who understand study procedures and methods, voluntarily participate in this trial, follow study-related instructions, and sign a written informed consent form.
Exclusion criteria
1. Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematologic, metabolic, endocrine, neurologic, psychiatric disease, or any condition that may interfere with the subject successfully completing the trial 2. Subjects with history of or current malignancy; 3. Participant who the researchers believe that there are volunteers who are not suitable for
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of the Adverse Events that are related to the single dose treatment | from baseline to Day 11 | single dose safety |
| Number of the Adverse Events that are related to the multiple dose treatment from baseline to Day 18 | from baseline to Day 18 | multiple dose safety |
Countries
China
Contacts
Primary ContactJing Xu
Outcome results
None listed