The purpose of this study is to examine the safety and tolerability of HFB30132A when it is given by single intravenous infusion in Chinese healthy participants.
This is a Phase I, randomized, double-blind, placebo-controlled, dose escalation study in Chinese healthy volunteers. The study will comprise of: 1. A Screening Period of up to 30 days (Day -30 through Day -1); 2. A Treatment Period during which participants will be resident at the Observation Unit from Day -1, 1 day before Investigational Medicinal Product (IMP) administration (on Day 1) until at least 48 hours (Day 3) after IMP administration. Participants will be discharged on Day 3 after all safety and/or pharmacokinetic (PK) evaluations have been completed, and 3. A Follow up Period lasting 270 days after the IMP dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
Huashan Hospital
Shanghai, China
Number of participants with treatment emergent serious adverse events (TESAEs)
Number of participants experiencing TESAEs
Time frame: From Day 1 to up to Day 30 after the single dose administration of HFB30132A
Number of participants with treatment emergent adverse events of special interest (TEAESI)
Safety and tolerability will be evaluated in terms of number of participants with TEAESI (hypersensitivity / anaphylactic reaction / local tolerability)
Time frame: From Day 1 to up to Day 30 after the single dose administration of HFB30132A
Number of participants with treatment-emergent adverse events (TEAE)
Safety and tolerability will be evaluated in terms of number of participants with TEAE
Time frame: From Day 1 to up to Day 30 after the single dose administration of HFB30132A
Number of participants with changes in laboratory values, vital signs and ECG parameters
Safety and tolerability will be evaluated in terms of number of participants with changes in laboratory values, vital signs and ECG parameters
Time frame: From Day 1 to up to Day 30 after the single dose administration of HFB30132A
Maximum observed serum concentration (Cmax)
Time frame: From Day 1 to up to Day 30 of the last enrolled subject
Time of maximum serum concentration (Tmax)
Time frame: From Day 1 to up to Day 30 of the last enrolled subject
Area under the concentration vs. time curve (AUC0-last), AUC0-∞)
Time frame: From Day 1 to up to Day 30 of the last enrolled subject
Terminal half-life (T1/2)
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Time frame: From Day 1 to up to Day 30 of the last enrolled subject
Systemic clearance (CL)
Time frame: From Day 1 to up to Day 30 of the last enrolled subject
Apparent volume of distribution (Vd)
Time frame: From Day 1 to up to Day 30 of the last enrolled subject