Safety,Tolerability, and Pharmacokinetic of KPCXM18 for Injection

Phase 1

• Conditions: Healthy
• Interventions: Drug: KPCXM18; Drug: Placebo

• Registration Number: NCT04629287
• Lead Sponsor: Kunming Pharmaceuticals, Inc.

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.

Study Timeline

• Status Verified: 2020-11
• Study Start: 2020-11
• Study First Submitted: 2020-11-03
• Study First Submitted QC: 2020-11-09
• Study First Posted: 2020-11-16
• Last Update Submitted: 2020-11-17
• Last Update Posted: 2020-11-19
• Primary Completion: 2021-12
• Study Completion: 2022-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 102

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 .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
KPCXM18 for injection	Placebo	KPCXM18 ，freeze-dried powder,single and multiple ascending doses, Intravenous route
Placebo	Placebo	Placebo, freeze-dried powder,single and multiple ascending doses, Intravenous route
KPCXM18 for injection	KPCXM18	KPCXM18 ，freeze-dried powder,single and multiple ascending doses, Intravenous route
Placebo	KPCXM18	Placebo, freeze-dried powder,single and multiple ascending doses, Intravenous route

Primary Outcome Measures

Name	Time	Method
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 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 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 Outcome Measures

Name	Time	Method
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: 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: 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: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
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