This is a Phase 1, first in human (FIH), double-blind, placebo-controlled, single ascending dose (SAD) trial to assess the safety, tolerability, and pharmacokinetics (PK) of intravenously (IV) or subcutaneously (SC) injected ALIA-1758 in healthy male and female participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
53
Worldwide Clinical Trials Early Phase Services, LLC
San Antonio, Texas, United States
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence, severity, seriousness, and causality of treatment-emergent adverse events (TEAEs)
Time frame: Up to 85 days after dosing
Pharmacokinetic parameters of ALIA-1758 in healthy subjects: Cmax
Cmax
Time frame: 0-85 days after dosing
Pharmacokinetic parameters of ALIA-1758 in healthy subjects: T1/2
elimination half-life (T1/2)
Time frame: 0-85 days after dosing
Pharmacokinetic parameters of ALIA-1758 in healthy subjects: AUC
Area Under Curve (AUC)
Time frame: 0-85 days after dosing
Pharmacokinetic parameters of ALIA-1758 in healthy subjects: Bioavailability
Bioavailability after SC administration (F)
Time frame: 0-85 days after dosing
Pharmacokinetic parameters of ALIA-1758 in healthy subjects: Clearance
Clearance (CL)
Time frame: 0-85 days after dosing
Pharmacokinetic parameters of ALIA-1758 in healthy subjects: Volume of distribution
Volume of distribution (Vz)
Time frame: 0-85 days after dosing
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