Tolerability and Pharmacokinetics(PK)/Pharmacodynamics(PD) Study of GW003 in Healthy Subjects

Jiangsu T-mab BioPharma

Status and phase

Completed

Phase 1

Conditions

Chemotherapy-induced Neutropenia

Treatments

Biological: GW003

Study type

Interventional

Funder types

Industry

Identifiers

NCT02643901

Tmab-GW003-NP-03

Details and patient eligibility

About

This study is designed to access the tolerability and Pharmacokinetic/Pharmacodynamic (PK/PD) of single subcutaneous (SC) injection of GW003 in healthy subjects.

Enrollment

26 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

18 years to 45 years,Healthy male and female subjects.in the same dose group,the age difference between in 10 years
At least 50kg weight,BMI between 19 and 25kg/m2
No tobacco, alcohol and other bad habits
No history of drug allergy and biological agents allergy and other allergies
Not used biological agents and other drugs within three months before participated in this test
Not participated in other test or donated blood within three months before participated in this test
The medical history、physical examination、laboratory examination is normal or slightly abnormal
Subjects can obey the clinical trial protocol
Subjects, who are willing to follow the study protocol and provide written informed consent voluntarily.

Exclusion criteria

History of severe system disease(especially with the spleen swelling, adult respiratory distress syndrome and exudative pneumonia or sickle red blood cell anemia history)
History of drug allergy and biological agents allergy and other allergies
Subjects have used any long discharge period drugs will affect the present study within 3 months or are using drugs now
Subjects not to take effective contraceptive measures or have a family planning within one year， Pregnancy or nursing women
Subjects accepted major surgery 4 weeks before drug administration
Subjects vaccinated live vaccine 3 months before drug administration
Subjects with the history of drug abuse 5 years before drug administration
As the subjects participated 3 times or more than 3 times drug clinical trials within 1 year or as the subjects participated any drug clinical trial or donated blood within 3 months
Clinical and laboratory examination results is abnormal and have clinical significance
Subjects with poor compliance or have any unfavorable factors to participate in this test
Subjects can not complete the research
The researchers and their family members.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

26 participants in 5 patient groups

Ic-GW003 150ug/kg 4-8subjects

Experimental group

Description: