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Completed

NCT Number: NCT02643901

Tolerability and Pharmacokinetics(PK)/Pharmacodynamics(PD) Study of 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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Tianjin Hematonosis Hospital

Tianjin, Tianjin Municipality, 30020, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GW003

Biological

single SC injection

Primary outcomes

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: up to day 21

    To evaluate the safety and tolerance of single SC injection of GW003 in healthy subjects.

Secondary outcomes

  1. Frequency of subjects with Anti-GW003 antibody

    Time frame: 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

    Time frame: up to day 14

  3. area under the concentration-time curve(AUC) for GW003

    Time frame: up to day 14

Sponsors and collaborators

Lead sponsor

Jiangsu T-Mab Biopharma Co.,Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 31, 2015
Registry last updated
Aug 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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