Safety,Tolerability, and Pharmacokinetic of KPCXM18 for Injection

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

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

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Drug: KPCXM18; Drug: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 102
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: duo gao, ph.D; Phone Number: 3502 0871-68319868; Email: duo.gao@kpc.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kunming Pharmaceuticals, Inc.
• Investigators: Principal Investigator: yuhong huang, Prof., Second affiliated hospital of Tianjin university of tcm

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: November 3, 2020
• First Submitted That Met QC Criteria: November 9, 2020
• First Posted (Actual): November 16, 2020

Study Record Updates

• Last Update Posted (Actual): November 19, 2020
• Last Update Submitted That Met QC Criteria: November 17, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: stroke
• Other Study ID Numbers: KPCXM18/C101; CTR20202022 (Other Identifier: National Medical Products Administration)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No