Healthy
Conditions
Keywords
stroke
Brief summary
to assess the safety,Tolerability, and pharmacokinetic of KPCXM18 for injection in healthy subjects
Detailed description
To explore the safety, tolerance and pharmacokinetic of KPCXM18 for injection in healthy subjects by intravenous administration of different doses in single and multiple administration safety, tolerance and pharmacokinetic tests, and to obtain the safe dose range of the test drugs, thus providing dose design basis for phase II clinical trials.
Interventions
DRUGKPCXM18
KPCXM18,blind,freeze-dried powder,ascending doses，Intravenous route
DRUGPlacebo
Placebo,blind,freeze-dried powder,ascending doses，Intravenous route
Sponsors
Kunming Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
blind
Intervention model description
Randomized, blind, dose-incrementing, placebo controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. BMI between 19 and 26 kg/m2；male body weight not less than 50.0kg,female body weight not less than 45.0kg ； 2. General physical examination and physical and chemical examination are qualified. 3. Volunteers can communicate well with the investigator, understand and comply with the relevant requirements of the study, understand and sign the informed consent；
Exclusion criteria
1. Any condition that might interfere with the procedures or tests in this study; 2. Drinking（more than 14 units of alcohol per week） in 6 months ; 3. Smoking (more than 10 cigarettes per day or equal amount of tobacco) within 3 months (90 days) ; 4. Have special requirements on diet, or cannot follow a unified diet ; 5. Used a clinical trial drug within 3 months prior to administration ; 6. Positive blood pregnancy test of female subjects ; 7. Subjects may not be able to complete the study for other reasons or the investigator considers that they should not be included .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with abnormal vital signs | through study completion, an average of 2 week | To evaluate the safety KPCXM 18 for Injection with placebo after multiple intravenous dose in healthy Chinese subjects in terms of abnormal vital signs |
| Number of subjects with abnormal laboratory | through study completion, an average of 2 week | To evaluate the safety KPCXM 18 for Injection with placebo after multiple intravenous dose in healthy Chinese subjects in terms of abnormal laboratory |
| Number of subjects with abnormal physical examination | through study completion, an average of 2 week | To evaluate the safety KPCXM 18 for Injection with placebo after multiple intravenous dose in healthy Chinese subjects in terms of abnormal physical examination |
| Number of subjects with abnormal electrocardiogram | through study completion, an average of 2 week | To evaluate the safety KPCXM 18 for Injection with placebo after multiple intravenous dose in healthy Chinese subjects in terms of abnormal electrocardiogram |
| Number of subjects with adverse events | through study completion, an average of 2 week | To evaluate the safety KPCXM 18 for Injection with placebo after multiple intravenous dose in healthy Chinese subjects in terms of abnormal adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of KPCXM18 in plasma: AUC0-∞,ss | Time Frame: Between Day 1 to 14 days | To characterize the pharmacokinetic parameters：AUC0-∞,ss of KPCXM18 after the 14th day administer |
| Pharmacokinetics of KPCXM18 in plasma: Cmax | Time Frame: Between Day 1 to 7 days | To characterize the pharmacokinetic parameters：Cmax of KPCXM18 after the first day administer |
| Pharmacokinetics of KPCXM18 in plasma: Tmax,ss | Time Frame: Between Day 1 to 14 days | To characterize the pharmacokinetic parameters：Tmax,ss of KPCXM18 after the 14th day administer |
| Pharmacokinetics of KPCXM18 in plasma: Tmax | Time Frame: Between Day 1 to 7 days | To characterize the pharmacokinetic parameters：Tmax of KPCXM18 after the first day administer |
| Pharmacokinetics of KPCXM18 in plasma: AUC0-∞ | Time Frame: Between Day 1 to 7 days | To characterize the pharmacokinetic parameters： AUC0-∞ of KPCXM18 after the first day administer |
| Pharmacokinetics of KPCXM18 in plasma:t1/2 | Time Frame: Between Day 1 to 7 days | To characterize the pharmacokinetic parameters： t1/2 of KPCXM18 after the |
| Pharmacokinetics of KPCXM18 in plasma: Cmax,ss | Time Frame: Between Day 1 to 14 days | To characterize the pharmacokinetic parameters：Cmax,ss of KPCXM18 after the 14th day administer |
Contacts
Primary Contactduo gao, ph.D
Outcome results
None listed