A block-randomized, double-blind, placebo-controlled, single-dose escalating, phase I clinical trial to evaluate the safety, tolerability and pharmacokinetics of YHB1411-2 in healthy male volunteers
First in human Study
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
49
IV infusion
IV infusion
IV infusion
Samsung Medical Center
Seoul, Irwon-dong, Gangnam-gu, South Korea
Safety Evaluation
Adverse Events, Physical examination, ECG, Vital sign, Clinical Laboratory Tests results, Chest X-ray
Time frame: Participants will be followed for the duration of hospital stay(an expected average of 1 week) and out-patient visit for 8 weeks → Specified timepoints in the protocol.
Pharmacokinetic Evaluation
Time frame: PK sampling : participants will be followed for the duration of hospital stay(an expected average of 1 week) and out-patient visit for 8 weeks → Specified timepoints in the protocol.
Immunogenicity Evaluation
1. HAHA (Human anti human antibodies) measurement 2. Neutralizing Antibody measurement: only if antibody formation has verified
Time frame: HAHA measurement(blood sampling): pre-dose and out-patient visit for 8 weeks → Specified timepoints in the protocol.
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IV infusion
IV infusion
IV infusion