Phase I Study to Investigate the Pharmacokinetics, Safety, and Tolerability of BMT101 in Healthy Male Volunteers
A Randomized, Single Blind, Single Dose, Placebo-controlled, Dose-escalation Phase I Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Intradermal Dosage Form of BMT101 in Healthy Male Volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
32
Hugel
Seoul, South Korea
Safety Evaluation: Severity and frequency of reported adverse events, clinically-relevant changes in physical exams or laboratory testing assessed by medical personnel
Assess severity and frequency of reported adverse events, clinically-relevant changes in physical exams or laboratory testing assessed by medical personnel
Time frame: 14 days
Pharmacokinetics (PK) of BMT101 by intradermal injection following single dose: Cmax
Determine peak whole blood concentration (Cmax)
Time frame: 4 days
Pharmacokinetics (PK) of BMT101 by intradermal injection following single dose: AUC
Determine area under the whole blood concentration versus time curve (AUC)
Time frame: 4 days
Pharmacokinetics (PK) of BMT101 by intradermal injection following single dose: T½
Determine drug half-life in whole blood (T½)
Time frame: 4 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.