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

Sponsor
Jiangsu T-Mab Biopharma Co.,Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT02643901
Collaborator
(none)
26
Enrollment
1
Location
5
Arms
13.3
Duration (Months)
2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: GW003
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Sep 1, 2015
Actual Primary Completion Date :
Oct 10, 2016
Actual Study Completion Date :
Oct 10, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. half-life(consist of distribution and elimination half-life) for GW003 [up to day 14]

  3. area under the concentration-time curve(AUC) for GW003 [up to day 14]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tianjin Hematonosis Hospital Tianjin Tianjin China 30020

Sponsors and Collaborators

  • Jiangsu T-Mab Biopharma Co.,Ltd

Investigators

  • Principal Investigator: Qi Junyuan, doctor, Tianjin Hematonosis Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiangsu T-Mab Biopharma Co.,Ltd
ClinicalTrials.gov Identifier:
NCT02643901
Other Study ID Numbers:
  • Tmab-GW003-NP-03
First Posted:
Dec 31, 2015
Last Update Posted:
Aug 18, 2017
Last Verified:
Sep 1, 2016
Additional relevant MeSH terms:
Neutropenia

Study Results

No Results Posted as of Aug 18, 2017