To evaluate the safety and tolerability of single subcutaneous injection of Genakumab for Injection in Chinese healthy adult volunteers
There are 5 dose groups with 8 participants in each group, including 6 participants in the experimental group and 2 participants in the placebo control group. Since the strength of experimental drug is 150mg/1ml/ bottle, participants with a single dose of more than 150mg need to be given subcutaneously at different sites in two or more times
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
40
150 mg/1ml/bottle, single subcutaneous injection.
The placebo contains other excipients except Genakumab, and its appearance is consistent with that of Genakumab for injection, 150 mg/1ml/bottle, single subcutaneous injection.
Clinical Pharmacology Research Center of Peking Union Medical College Hospital
Beijing, China
RECRUITINGMaximum observed serum Genakumab concentration
Time frame: Baseline, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 168h, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113 after administration
Area under the serum Genakumab concentration-time curve
Time frame: Baseline, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 168h, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113 after administration
Measurement of the serum IL-1β for pharmacodynamics study
Time frame: Baseline, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 168h, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113 after administration
The frequency of adverse events (AE)
Time frame: From screening to follow-up period (up to day 22)
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