Overall design: Single-center, randomized, blinded, placebo-controlled single- and multiple-ascending dose study in healthy adult subjects.
This first-time-in-human (FTIH) SAD and MAD studies in healthy adult subjects will be conducted at one site in the United States of America (USA) on IV and SC VIB9600. Study acquired from Horizon in 2024. Originally Viela Bio was the sponsor.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
24
CTI Clinical Trial & Consulting Clinical Research Center
Cincinnati, Ohio, United States
Safety and tolerability of single and multiple doses of VIB9600
Treatment-emergent adverse events that occur on or after the day of IP administration.
Time frame: 113 days
PK of VIB9600 following single- and multiple- dose administration
Concentration of VIB9600 in serum at different time points after IP administration.
Time frame: SAD- Days 1, 2, 3, 5, 8, 16, 29, 43, 57, 85, 113; MAD- Days 1, 3, 8, 15, 22, 29, 32, 36, 43, 57, 86, 113
Immunogenicity of VIB9600 following single- and multiple-dose administration.
Immunogenicity as measured by the presence of anti-drug antibodies (ADA) to VIB9600
Time frame: SAD- Days 1, 15, 29, 57, 85, 113; MAD- Days 1, 15, 29, 57, 85, 113
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