This study is designed to access the tolerability and Pharmacokinetic/Pharmacodynamic (PK/PD) of single subcutaneous (SC) injection of GW003 in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
single SC injection
Tianjin Hematonosis Hospital
Tianjin, Tianjin Municipality, China
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.
Time frame: up to day 21
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.
Time frame: up to 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
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