The purpose of this study is to test the safety and tolerability of HFB30132A when it is given by intravenously to healthy participants. Blood tests will be done to check how much HFB30132A is in the bloodstream and how long the body takes to eliminate it. Participation may include up to ten visits to the study center.
This is a Phase I, first time in human, randomized, double-blind, placebo-controlled, and dose escalation study in 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 24 hours after IMP administration, will be discharged on Day 2 after all safety and/or pharmacokinetic (PK) evaluations have been completed, and 3. A Follow up Period lasting 180 days after the IMP dose. The study will be conducted at a single study center in Cincinnati.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, United States
Number of participants with treatment emergent serious adverse events (TESAEs)
Number of participants experiencing TEAEs
Time frame: From Day 1 to up to Day 30 of the last enrolled subject
Number of participants with treatment emergent adverse events (TEAE) of special interest
Safety and tolerability will be evaluated in terms of number of participants with TEAEs of special interest (hypersensitivity / anaphylactic reaction / local tolerability)
Time frame: From Day 1 to up to Day 30 of the last enrolled subject
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 of the last enrolled subject
Maximum observed serum concentration (Cmax)
Time frame: From Day 1 to up to Day 30 of the last enrolled subject
Minimum observed serum concentration (Cmin)
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)
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
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Steady-state volume of distribution (Vss)
Time frame: From Day 1 to up to Day 30 of the last enrolled subject
Number of participants with treatment-emergent adverse events (TEAEs)
Safety and tolerability will be evaluated in terms of number of participants with TEAEs
Time frame: From Day 1 to up to last follow-up day (Day 180)
Number of participants with treatment-emergent serious adverse events (TESAEs)
Safety and tolerability will be evaluated in terms of number of participants with TESAEs
Time frame: From Day 1 to up to last follow-up day (Day 180)
Maximum observed serum HFB30132A concentration (Cmax) in nasal and oral secretions
Time frame: From Day 1 to up to last follow-up day (Day 180)
Minimum observed serum HFB30132A concentration (Cmin) in nasal and oral secretions
Time frame: From Day 1 to up to last follow-up day (Day 180)
Time of maximum serum HFB30132A concentration (Tmax) in nasal and oral secretions
Time frame: From Day 1 to up to last follow-up day (Day 180)
Area under the concentration vs. time curve (AUC0-last), AUC0-∞) in nasal and oral secretions
Time frame: From Day 1 to up to last follow-up day (Day 180)
Terminal half-life (T1/2) of HFB30132A in nasal and oral secretions
Time frame: From Day 1 to up to last follow-up day (Day 190)
Systemic clearance (CL) of HFB30132A in nasal and oral secretions
Time frame: From Day 1 to up to last follow-up day (Day 180)
Steady-state volume of distribution (Vss) of HFB30132A in nasal and oral secretions
Time frame: From Day 1 to up to last follow-up day (Day 180)
HFB30132A Anti-drug antibodies
Presence or absence of antibodies against HFB30132A over time
Time frame: From Day 1 to up to last follow-up day (Day 180)