Safety,Tolerability, and Pharmacokinetic of KPCXM18 for Injection

KPC Pharmaceuticals

Status and phase: Unknown; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: KPCXM18

Study type: Interventional

Funder types: Industry

Identifiers

NCT04629287

KPCXM18/C101

CTR20202022 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 102 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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 .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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102 participants in 2 patient groups, including a placebo group

KPCXM18 for injection

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: KPCXM18

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: KPCXM18