The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of a single subcutaneous dose of UB-621 in healthy volunteers.
This is a phase I, open-label, single dose, dose escalation study in healthy volunteers. Eligible volunteers will be sequentially enrolled into four escalating-dose cohorts at a study site. After administration of a single subcutaneous dose of UB-621, subjects will be followed for 70 or 112 days and monitored for safety, tolerability, and pharmacokinetics parameters.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
15
100 mg/ml, subcutaneous injection
Taipei Veterans General Hospital
Taipei, Taiwan
Number of participants with adverse events
Time frame: Up to 70 or 112 days
Peak concentration of UB-621
Time frame: Up to 70 or 112 days
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