The aim of this study is to investigate the safety and tolerability of HB0034 in healthy subjects following a single dose or multiple dose.
This study consisted of a single-dose escalation study and a multi-dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of HB0034 in Chinese healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Recombinant Humanized Anti-IL-36R Monoclonal antibody
HB0034 matching Palcebo
Central Hospital affiliated to Shandong First Medical University
Jinan, Shandong, China
RECRUITINGPercentage of subjects with drug related adverse events (AEs)
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational drug
Time frame: up to 113 days
Cmax
The maximum measured concentration of the analysis in plasma
Time frame: Up to 113 days
AUC0-infinity
The area under the concentration-time curve of the analysis in plasma over the time interval from 0 extrapolated to infinity
Time frame: up to 113 days
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