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

Primary Purpose

Chemotherapy-induced Neutropenia

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
GW003
Sponsored by
Jiangsu T-Mab Biopharma Co.,Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chemotherapy-induced Neutropenia

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts 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.

Sites / Locations

  • Tianjin Hematonosis Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Ic-GW003 150ug/kg 4-8subjects

Ic-GW003 300ug/kg 6-8subjects

Ic-GW003 500ug/kg 6-8subjects

Ic-GW003 650ug/kg 6-8subjects

Ic-GW003 850ug/kg 6-8subjects

Arm Description

Biological/Vaccine:GW003 freeze-dried powder single SC injection

Biological/Vaccine:GW003 freeze-dried powder single SC injection

Biological/Vaccine:GW003 freeze-dried powder single SC injection

Biological/Vaccine:GW003 freeze-dried powder single SC injection

Biological/Vaccine:GW003 freeze-dried powder single SC injection

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
half-life(consist of distribution and elimination half-life) for GW003
area under the concentration-time curve(AUC) for GW003

Full Information

First Posted
November 30, 2015
Last Updated
August 15, 2017
Sponsor
Jiangsu T-Mab Biopharma Co.,Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02643901
Brief Title
Tolerability and Pharmacokinetics(PK)/Pharmacodynamics(PD) Study of GW003 in Healthy Subjects
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
October 10, 2016 (Actual)
Study Completion Date
October 10, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu T-Mab Biopharma Co.,Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Neutropenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ic-GW003 150ug/kg 4-8subjects
Arm Type
Experimental
Arm Description
Biological/Vaccine:GW003 freeze-dried powder single SC injection
Arm Title
Ic-GW003 300ug/kg 6-8subjects
Arm Type
Experimental
Arm Description
Biological/Vaccine:GW003 freeze-dried powder single SC injection
Arm Title
Ic-GW003 500ug/kg 6-8subjects
Arm Type
Experimental
Arm Description
Biological/Vaccine:GW003 freeze-dried powder single SC injection
Arm Title
Ic-GW003 650ug/kg 6-8subjects
Arm Type
Experimental
Arm Description
Biological/Vaccine:GW003 freeze-dried powder single SC injection
Arm Title
Ic-GW003 850ug/kg 6-8subjects
Arm Type
Experimental
Arm Description
Biological/Vaccine:GW003 freeze-dried powder single SC injection
Intervention Type
Biological
Intervention Name(s)
GW003
Intervention Description
single SC injection
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
To evaluate the safety and tolerance of single SC injection of GW003 in healthy subjects.
Time Frame
up to day 21
Secondary Outcome Measure Information:
Title
Frequency of subjects with Anti-GW003 antibody
Description
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.
Time Frame
up to 6 months after the trial
Title
half-life(consist of distribution and elimination half-life) for GW003
Time Frame
up to day 14
Title
area under the concentration-time curve(AUC) for GW003
Time Frame
up to day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qi Junyuan, doctor
Organizational Affiliation
Tianjin Hematonosis Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tianjin Hematonosis Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
30020
Country
China

12. IPD Sharing Statement

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

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