Safety,Tolerability, and Pharmacokinetic of KPCXM18 for Injection

Study Overview
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Brief Summary
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to assess the safety,Tolerability, and pharmacokinetic of KPCXM18 for injection in healthy subjects

Detailed Description
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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.

Official Title
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A Randomized, Blind, Placebo-controlled,Single Andmultiple Ascending Dose Study to Assess the Safety,Tolerability, and Pharmacokinetic of KPCXM18 for Injection in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: KPCXM18
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI between 19 and 26 kg/m2；male body weight not less than 50.0kg,female body weight not less than 45.0kg ； General physical examination and physical and chemical examination are qualified. 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: Any condition that might interfere with the procedures or tests in this study; Drinking（more than 14 units of alcohol per week） in 6 months ; Smoking (more than 10 cigarettes per day or equal amount of tobacco) within 3 months (90 days) ; Have special requirements on diet, or cannot follow a unified diet ; Used a clinical trial drug within 3 months prior to administration ; Positive blood pregnancy test of female subjects ; Subjects may not be able to complete the study for other reasons or the investigator considers that they should not be included .

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Randomized, blind, dose-incrementing, placebo controlled
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KPCXM18 for injection<br>KPCXM18 ，freeze-dried powder,single and multiple ascending doses, Intravenous route | Drug: KPCXM18<br>* KPCXM18,blind,freeze-dried powder,ascending doses，Intravenous route<br>Drug: Placebo<br>* Placebo,blind,freeze-dried powder,ascending doses，Intravenous route<br>|
| Placebo Comparator: Placebo<br>Placebo, freeze-dried powder,single and multiple ascending doses, Intravenous route | Drug: KPCXM18<br>* KPCXM18,blind,freeze-dried powder,ascending doses，Intravenous route<br>Drug: Placebo<br>* Placebo,blind,freeze-dried powder,ascending doses，Intravenous route<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with abnormal vital signs | To evaluate the safety KPCXM 18 for Injection with placebo after multiple intravenous dose in healthy Chinese subjects in terms of abnormal vital signs | through study completion, an average of 2 week | 
| Number of subjects with abnormal laboratory | To evaluate the safety KPCXM 18 for Injection with placebo after multiple intravenous dose in healthy Chinese subjects in terms of abnormal laboratory | through study completion, an average of 2 week | 
| Number of subjects with abnormal physical examination | To evaluate the safety KPCXM 18 for Injection with placebo after multiple intravenous dose in healthy Chinese subjects in terms of abnormal physical examination | through study completion, an average of 2 week | 
| Number of subjects with abnormal electrocardiogram | To evaluate the safety KPCXM 18 for Injection with placebo after multiple intravenous dose in healthy Chinese subjects in terms of abnormal electrocardiogram | through study completion, an average of 2 week | 
| Number of subjects with adverse events | To evaluate the safety KPCXM 18 for Injection with placebo after multiple intravenous dose in healthy Chinese subjects in terms of abnormal adverse events | through study completion, an average of 2 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of KPCXM18 in plasma: Cmax | To characterize the pharmacokinetic parameters：Cmax of KPCXM18 after the first day administer | Time Frame: Between Day 1 to 7 days | 
| Pharmacokinetics of KPCXM18 in plasma: Tmax | To characterize the pharmacokinetic parameters：Tmax of KPCXM18 after the first day administer | Time Frame: Between Day 1 to 7 days | 
| Pharmacokinetics of KPCXM18 in plasma: AUC0-∞ | To characterize the pharmacokinetic parameters： AUC0-∞ of KPCXM18 after the first day administer | Time Frame: Between Day 1 to 7 days | 
| Pharmacokinetics of KPCXM18 in plasma:t1/2 | To characterize the pharmacokinetic parameters： t1/2 of KPCXM18 after the | Time Frame: Between Day 1 to 7 days | 
| Pharmacokinetics of KPCXM18 in plasma: Cmax,ss | To characterize the pharmacokinetic parameters：Cmax,ss of KPCXM18 after the 14th day administer | Time Frame: Between Day 1 to 14 days | 
| Pharmacokinetics of KPCXM18 in plasma: AUC0-∞,ss | To characterize the pharmacokinetic parameters：AUC0-∞,ss of KPCXM18 after the 14th day administer | Time Frame: Between Day 1 to 14 days | 
| Pharmacokinetics of KPCXM18 in plasma: Tmax,ss | To characterize the pharmacokinetic parameters：Tmax,ss of KPCXM18 after the 14th day administer | Time Frame: Between Day 1 to 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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