Safety,Tolerability, and Pharmacokinetic of KPCXM18 for Injection

Healthy Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04629287
• Other study ID #: KPCXM18/C101
• Secondary ID: CTR20202022
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: November 2020
• Est. completion date: February 2022

Study information

• Verified date: November 2020
• Source: Kunming Pharmaceuticals, Inc.
• Contact: duo gao, ph.D
• Phone: 0871-68319868
• Email: duo.gao[@]kpc.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 102
• Est. completion date: February 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• KPCXM18
KPCXM18,blind,freeze-dried powder,ascending doses,Intravenous route
• Placebo
Placebo,blind,freeze-dried powder,ascending doses,Intravenous route

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kunming Pharmaceuticals, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Pharmacokinetics of KPCXM18 in plasma: AUC0-8	To characterize the pharmacokinetic parameters: AUC0-8 of KPCXM18 after the first day administer	Time Frame: Between Day 1 to 7 days
Secondary	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
Secondary	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
Secondary	Pharmacokinetics of KPCXM18 in plasma: AUC0-8,ss	To characterize the pharmacokinetic parameters:AUC0-8,ss of KPCXM18 after the 14th day administer	Time Frame: Between Day 1 to 14 days
Secondary	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