Clinical trial NCT04629287: Safety,Tolerability, and Pharmacokinetic of KPCXM18 for Injection
Official title: A Randomized, Blind, Placebo-controlled,Single Andmultiple Ascending Dose Study to Assess the Safety,Tolerability, and Pharmacokinetic of KPCXM18 for Injection in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Keywords: stroke
Lead sponsor: Kunming Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2020-11-16
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Randomized, blind, dose-incrementing, placebo controlled
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 .

Primary outcomes:
measure: Number of subjects with abnormal vital signs
timeFrame: through study completion, an average of 2 week
measure: Number of subjects with abnormal laboratory
timeFrame: through study completion, an average of 2 week
measure: Number of subjects with abnormal physical examination
timeFrame: through study completion, an average of 2 week
measure: Number of subjects with abnormal electrocardiogram
timeFrame: through study completion, an average of 2 week
measure: Number of subjects with adverse events
timeFrame: through study completion, an average of 2 week
Secondary outcomes:
measure: Pharmacokinetics of KPCXM18 in plasma: Cmax
timeFrame: Time Frame: Between Day 1 to 7 days
measure: Pharmacokinetics of KPCXM18 in plasma: Tmax
timeFrame: Time Frame: Between Day 1 to 7 days
measure: Pharmacokinetics of KPCXM18 in plasma: AUC0-∞
timeFrame: Time Frame: Between Day 1 to 7 days
measure: Pharmacokinetics of KPCXM18 in plasma:t1/2
timeFrame: Time Frame: Between Day 1 to 7 days
measure: Pharmacokinetics of KPCXM18 in plasma: Cmax,ss
timeFrame: Time Frame: Between Day 1 to 14 days
measure: Pharmacokinetics of KPCXM18 in plasma: AUC0-∞,ss
timeFrame: Time Frame: Between Day 1 to 14 days
measure: Pharmacokinetics of KPCXM18 in plasma: Tmax,ss
timeFrame: Time Frame: Between Day 1 to 14 days
Other outcomes:
Locations:
Study officials:
affiliation: Second Affiliated Hospital of Tianjin University of TCM
name: yuhong huang, Prof.
role: PRINCIPAL_INVESTIGATOR
References: