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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 He

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.

Detailed Summary:
Sponsor: Jiangsu T-Mab Biopharma Co.,Ltd

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • half-life(consist of distribution and elimination half-life) for GW003 [ Time Frame: up to day 14 ]
  • area under the concentration-time curve(AUC) for GW003 [ Time Frame: up to day 14 ]


Original Secondary Outcome: Same as current

Information By: Jiangsu T-Mab Biopharma Co.,Ltd

Dates:
Date Received: November 30, 2015
Date Started: September 2015
Date Completion: March 2017
Last Updated: January 12, 2017
Last Verified: September 2016