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

Chemotherapy-induced Neutropenia Clinical Trial

Official title:

The Single-Dose Tolerability and PK/PD Study of Recombinant (Expressed by Pichia Pastoris) Human Serum Albumin/Human Granulocyte-Colony Stimulating Factor(I) Fusion Protein for Injection (GW003) in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02643901
• Other study ID #: Tmab-GW003-NP-03
• Status: Completed
• Phase: Phase 1
• First received: November 30, 2015
• Last updated: August 15, 2017
• Start date: September 2015
• Est. completion date: October 10, 2016

Study information

• Verified date: September 2016
• Source: Jiangsu T-Mab Biopharma Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: October 10, 2016
• Est. primary completion date: October 10, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chemotherapy-induced Neutropenia
• Neutropenia

Intervention

Biological:
• GW003
single SC injection

Locations

Country	Name	City	State
China	Tianjin Hematonosis Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu T-Mab Biopharma Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	To evaluate the safety and tolerance of single SC injection of GW003 in healthy subjects.	up to day 21
Secondary	Frequency of subjects with Anti-GW003 antibody	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.	up to 6 months after the trial
Secondary	half-life(consist of distribution and elimination half-life) for GW003		up to day 14
Secondary	area under the concentration-time curve(AUC) for GW003		up to day 14