The purpose of this study is to evaluate the safety and PK of AZD7760 when given as an intravenous (IV) infusion to healthy Japanese adult participants.
This is a Phase I, randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety and PK of AZD7760, a mAb combination of suvratoxumab (labeled as MEDI4893) and AZD7745, in healthy Japanese adults. Two dosages of AZD7760 each administered as a single IV dose, will be assessed. Study details include: * A Screening Period of up to 28 days. * A Dosing Period of 3 days, in which a single IV infusion will be given on Day 1. * A Follow-up Period of 12 months from the time of administration of the study intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
18
Research Site
Sumida-ku, Japan
RECRUITINGOccurrence of Adverse Events (AEs)
To evaluate the safety of AZD7760 administered as a single IV Dose A or Dose B in healthy Japanese adult participants.
Time frame: Day 1 to Day 181
Occurrence of Medically-attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)
To evaluate the safety of AZD7760 administered as a single IV Dose A or Dose B in healthy Japanese adult participants.
Time frame: Day 1 to Day 361
Maximum observed serum (peak) drug concentration (Cmax)
To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.
Time frame: Day 1 to Day 361
Time to reach peak or maximum observed concentration following drug administration (tmax)
To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.
Time frame: Day 1 to Day 361
Terminal elimination half-life (t½λz)
To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.
Time frame: Day 1 to Day 361
Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast)
To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.
Time frame: Day 1 to Day 361
Area under the concentration-time curve from time 0 to infinity (AUCinf)
To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.
AstraZeneca Clinical Study Information Center
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 1 to Day 361
Volume of distribution at steady state (Vss)
To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.
Time frame: Day 1 to Day 361
Volume of distribution based on the terminal phase (Vz)
To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.
Time frame: Day 1 to Day 361
Incidence of Anti-drug antibody (ADA)
To evaluate ADA responses to AZD7760 in serum of healthy Japanese adult participants
Time frame: Day 1 to Day 361