This is a randomized, double-blind, placebo-controlled, single ascending dose phase I clinical study to evaluate the safety, tolerability, PK and immunogenicity of SSGJ-626 in healthy adult subjects after single subcutaneous injection.
Six dose groups are planned for dose escalation in this study. Subjects in all dose groups will receive a single subcutaneous injection. Group S1 follows open-labeled, single-arm design, Groups S2 to S6 follow randomized, double-blinded, placebo-control design. Blood samples will be collected for PK, immunogenicity, biomarkers, laboratory tests, etc. according to the study schedule throughout the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
Shanghai General Hospital
Shanghai, China
RECRUITINGNumber of participants with Adverse Events
Incidence of adverse events will be summarized by SOC and PT for each treatment group, and also be summarized by severity and association with the study treatments.
Time frame: 90 days
Cmax
Peak concentration (Cmax) will be calculated.
Time frame: 90 days
Tmax
Time to peak concentration (Tmax) will be calculated.
Time frame: 90 days
AUC0-last
Area under the concentration-time curve from time 0 to the time point of last measurable concentration post-dose (AUC0-last) will be calculated.
Time frame: 90 days
Incidence of Anti-Drug Antibody
Anti-drug antibody (ADA) positive rate and titer will be calculated. Incidence of neutralizing antibody (Nab) if ADA is positive.
Time frame: 90 days
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