A study to investigate the safety, tolerability, and pharmacokinetics of the monoclonal antibody VYD222 in healthy adult participants.
This is a Phase I, first-in-human, randomized, triple blind, single escalating dose study to evaluate the safety and tolerability of VYD222, a monoclonal antibody targeting SARS-CoV-2, in healthy adult volunteers. The primary objective is to evaluate the safety and tolerability of multiple dose levels of VYD222 after a single administration in healthy participants. The secondary objective is to evaluate the plasma pharmacokinetics and immunogenicity of VYD222 after administration in healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
30
Linear Clinical Research
Joondalup, Western Australia, Australia
Incidence of TEAEs (including AEs and SAEs)
Time frame: Through 12 Months
Incidence of ADAs against VYD222
Time frame: 12 Months
Assessment of PK Parameter: area under the concentration-time curve from time zero extrapolated to infinity for VYD222
Time frame: 12 Months
Assessment of PK Parameter: area under the concentration-time curve from time zero to the last measurable concentration for VYD222
Time frame: 12 Months
Assessment of PK Parameter: area under the concentration-time curve from time zero to t for VYD222
Time frame: 12 Months
Assessment of PK Parameter: Cmax (maximum serum concentration)
Time frame: 12 Months
Assessment of PK Parameter: Tmax (time to reach maximum serum concentration)
Time frame: 12 Months
Assessment of PK Parameter: Clearance of VYD222
Time frame: 12 Months
Assessment of PK Parameter: Half-life of VYD222
Time frame: 12 Months
Assessment of PK Parameter: volume of distribution at steady state of VYD222
Time frame: 12 Months
Assessment of PK Parameter: volume of distribution during terminal phase of VYD222
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 12 Months