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

Phase 1

Completed

• Conditions: Chemotherapy-induced Neutropenia

• Registration Number: NCT02643901
• Lead Sponsor: Jiangsu T-Mab Biopharma Co.,Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-11-30
• Study First Submitted QC: 2015-12-29
• Study First Posted: 2015-12-31
• Status Verified: 2016-09
• Primary Completion: 2016-10-10
• Study Completion: 2016-10-10
• Last Update Submitted: 2017-08-15
• Last Update Posted: 2017-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	up to day 21	To evaluate the safety and tolerance of single SC injection of GW003 in healthy subjects.

Secondary Outcome Measures

Name	Time	Method
half-life(consist of distribution and elimination half-life) for GW003	up to day 14
area under the concentration-time curve(AUC) for GW003	up to day 14
Frequency of subjects with Anti-GW003 antibody	up to 6 months after the trial	anti-GW003 was detected pre-dose and at the last visit,if there exist positive anti-GW003 antibody, another detected should be conducted 6 months after the trial.

Trial Locations

Locations (1)

Tianjin Hematonosis Hospital; 🇨🇳 Tianjin, Tianjin, China