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

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

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

Study Overview

• Status: Completed
• Conditions: Chemotherapy-induced Neutropenia
• Intervention / Treatment: Biological: GW003

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 30020
      • Tianjin Hematonosis Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ic-GW003 150ug/kg 4-8subjects; Biological/Vaccine:GW003 freeze-dried powder single SC injection	Biological: GW003; single SC injection
Experimental: Ic-GW003 300ug/kg 6-8subjects; Biological/Vaccine:GW003 freeze-dried powder single SC injection	Biological: GW003; single SC injection
Experimental: Ic-GW003 500ug/kg 6-8subjects; Biological/Vaccine:GW003 freeze-dried powder single SC injection	Biological: GW003; single SC injection
Experimental: Ic-GW003 650ug/kg 6-8subjects; Biological/Vaccine:GW003 freeze-dried powder single SC injection	Biological: GW003; single SC injection
Experimental: Ic-GW003 850ug/kg 6-8subjects; Biological/Vaccine:GW003 freeze-dried powder single SC injection	Biological: GW003; single SC injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Jiangsu T-Mab Biopharma Co.,Ltd
• Investigators: Principal Investigator: Qi Junyuan, doctor, Tianjin Hematonosis Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): October 10, 2016
• Study Completion (Actual): October 10, 2016

Study Registration Dates

• First Submitted: November 30, 2015
• First Submitted That Met QC Criteria: December 29, 2015
• First Posted (Estimate): December 31, 2015

Study Record Updates

• Last Update Posted (Actual): August 18, 2017
• Last Update Submitted That Met QC Criteria: August 15, 2017
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Neutropenia
• Other Study ID Numbers: Tmab-GW003-NP-03