Safety,Tolerability, and Pharmacokinetic of KPCXM18 for Injection

NCT04629287 | Unknown Phase 1

• 2 other identifiers: KPCXM18/C101CTR20202022
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Keywords

stroke

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• Pharmacokinetics of KPCXM18 in plasma: Cmax

  Time Frame: Between Day 1 to 7 days

• Pharmacokinetics of KPCXM18 in plasma: Tmax

  Time Frame: Between Day 1 to 7 days

• Pharmacokinetics of KPCXM18 in plasma: AUC0-∞

  Time Frame: Between Day 1 to 7 days

• Pharmacokinetics of KPCXM18 in plasma:t1/2

  Time Frame: Between Day 1 to 7 days

• Pharmacokinetics of KPCXM18 in plasma: Cmax,ss

  Time Frame: Between Day 1 to 14 days

Study Arms (2)

KPCXM18 for injection

EXPERIMENTAL

KPCXM18 ，freeze-dried powder,single and multiple ascending doses, Intravenous route

Drug: KPCXM18; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Placebo, freeze-dried powder,single and multiple ascending doses, Intravenous route

Drug: KPCXM18; Drug: Placebo

Interventions

KPCXM18 DRUG

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

KPCXM18 for injection; Placebo

Placebo DRUG

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

KPCXM18 for injection; Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI between 19 and 26 kg/m2；male body weight not less than 50.0kg,female body weight not less than 45.0kg ；
• General physical examination and physical and chemical examination are qualified.
• Volunteers can communicate well with the investigator, understand and comply with the relevant requirements of the study, understand and sign the informed consent；

You may not qualify if:

• Any condition that might interfere with the procedures or tests in this study;
• Drinking（more than 14 units of alcohol per week） in 6 months ;
• Smoking (more than 10 cigarettes per day or equal amount of tobacco) within 3 months (90 days) ;
• Have special requirements on diet, or cannot follow a unified diet ;
• Used a clinical trial drug within 3 months prior to administration ;
• Positive blood pregnancy test of female subjects ;
• Subjects may not be able to complete the study for other reasons or the investigator considers that they should not be included .

Sponsors & Collaborators

• Kunming Pharmaceuticals, Inc.: lead

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• yuhong huang, Prof.

  Second Affiliated Hospital of Tianjin University of TCM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

duo gao, ph.D

CONTACT

0871-68319868; duo.gao@kpc.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: blind
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, blind, dose-incrementing, placebo controlled

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: November 16, 2020
• Study Start: November 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: February 1, 2022
• Last Updated: November 19, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share