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Safety,Tolerability, and Pharmacokinetic of KPCXM18 for Injection

NCT ID: NCT04629287

Last Updated: 2020-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-30

Study Completion Date

2022-02-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Healthy

Keywords

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stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Randomized, blind, dose-incrementing, placebo controlled
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
blind

Study Groups

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KPCXM18 for injection

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

Group Type EXPERIMENTAL

KPCXM18

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

KPCXM18

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

Interventions

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KPCXM18

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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 .
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kunming Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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yuhong huang, Prof.

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital of Tianjin University of TCM

Central Contacts

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duo gao, ph.D

Role: CONTACT

Phone: 0871-68319868

Email: [email protected]

Other Identifiers

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CTR20202022

Identifier Type: OTHER

Identifier Source: secondary_id

KPCXM18/C101

Identifier Type: -

Identifier Source: org_study_id