Safety,Tolerability, and Pharmacokinetic of KPCXM18 for Injection

Kunming Pharmaceuticals, Inc.102 enrolled

Overview

to assess the safety,Tolerability, and pharmacokinetic of KPCXM18 for injection in healthy subjects

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

102

Conditions

Healthy

Interventions

KPCXM18DRUG

KPCXM18,blind,freeze-dried powder,ascending doses，Intravenous route

PlaceboDRUG

Placebo,blind,freeze-dried powder,ascending doses，Intravenous route

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 .

Outcomes

Primary Outcomes

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