The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of zampilimab in healthy study participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
16
Participants will receive a single intravenous dose of zampilimab at a pre-specified time point.
Participants will receive matching placebo at a pre-specified time point to maintain the blinding.
Up0105 001
London, United Kingdom
Incidents of treatment-emergent adverse events (TEAEs) through the Safety Follow-up (SFU) Visit
A treatment-emergent adverse event (TEAE) is defined as any event not present prior to the administration of investigational medicinal product (IMP) or any unresolved event already present before administration of IMP that worsens in intensity following exposure to the treatment.
Time frame: From Day 1 (Start of Treatment Period) to the end of Safety Follow-up (up to 120 days)
Maximum intensity of treatment-emergent adverse events (TEAEs) through the Safety Follow-up (SFU) Visit
Maximum intensity across all incidents of each TEAE for each study participant
Time frame: From Day 1 (Start of Treatment Period) to the end of Safety Follow-up (up to 120 days)
Maximum zampilimab serum concentration (Cmax)
Cmax: Maximum observed zampilimab serum concentration
Time frame: From Day 1 (Start of Treatment Period) to the end of Safety Follow-up (up to 120 days)
Time to maximum zampilimab serum concentration (tmax)
tmax: Time to maximum observed zampilimab serum concentration
Time frame: From Day 1 (Start of Treatment Period) to the end of Safety Follow-up (up to 120 days)
Area under the zampilimab serum concentration-time curve from time zero to last quantifiable concentration (AUC0-t)
AUC0-t: Area under the zampilimab serum concentration-time curve from time zero (Day 1) to the last quantifiable concentration
Time frame: From Day 1 (Start of Treatment Period) at predefined time points to the last quantifiable concentration (up to 120 days)
Area under the zampilimab serum concentration-time curve from time zero to infinity (AUC)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
AUC: Area under the zampilimab serum concentration-time curve from time 0 (Day 1) to infinity
Time frame: Day 1 (Start of Treatment Period) at predefined time points (up to 120 days)
Clearance (CL) of zampilimab in serum
CL: volume of serum that is cleared from zampilimab per unit of time
Time frame: From Day 1 (Start of Treatment Period) to the end of Safety Follow-up (up to 120 days)
Apparent volume of distribution during terminal phase (Vz) of zampilimab
Vz: apparent volume of distribution during terminal phase
Time frame: From Day 1 (Start of Treatment Period) to the end of Safety Follow-up (up to 120 days)
Apparent terminal half-life (t1/2) of zampilimab
t1/2: terminal zampilimab serum half-life
Time frame: From Day 1 (Start of Treatment Period) to the end of Safety Follow-up (up to 120 days)