The purpose of this study is to measure safety, tolerability and PK of a single dose of AZD5148 administered via IV bolus or IM injection in healthy Japanese participants.
The purpose of this study is to measure safety, tolerability and PK of a single dose of AZD5148 administered via IV bolus or IM injection in healthy Japanese participants. Study details include: • There will be 12 planned visits (including screening visit) over a period of up to 56 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
16
Research Site
Sumida-ku, Japan
Number of Japanese participants with adverse events (AEs).
To evaluate the safety and tolerability of AZD5148 administered as a single IV or IM dose to healthy Japanese adult participants.
Time frame: From Randomization (Day -1 or Day 1) to Day 91
Number of participants with serious adverse events (SAEs)
To evaluate the safety and tolerability of AZD5148 administered as a single IV or IM dose to healthy Japanese adult participants.
Time frame: From Screening (Day -28 to Day -2) to final Follow-up Visit (Day 361)
Number of participants with adverse events of special interest (AESIs)
To evaluate the safety and tolerability of AZD5148 administered as a single IV or IM dose to healthy Japanese adult participants.
Time frame: From Randomization (Day -1 or Day 1) to final Follow-up Visit (Day 361)
Maximum observed drug concentration (Cmax)
To evaluate the single dose PK of AZD5148.
Time frame: From Day 1 until last Follow up visit (Day 361)
Time to reach maximum observed concentration (tmax)
To evaluate the single dose PK of AZD5148.
Time frame: From Day 1 until last Follow up visit (Day 361 days)
Time of last quantifiable concentration (tlast)
To evaluate the single dose PK of AZD5148.
Time frame: From Day 1 until last Follow up visit (Day 361 days)
Terminal elimination half-life, estimated as (ln2)/λz (t1/2λz)
To evaluate the single dose PK of AZD5148.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: From Day 1 until last Follow up visit (Day 361 days)
Area under concentration-curve from time 0 to the time of last quantifiable concentration (AUClast)
To evaluate the single dose PK of AZD5148.
Time frame: From Day 1 until last Follow up visit (Day 361 days)
Area under concentration-time curve from time 0 extrapolated to infinity (AUCinf)
To evaluate the single dose PK of AZD5148.
Time frame: From Day 1 until last Follow up visit (Day 361 days)
Volume of distribution at steady state (IV administration only) (Vss)
To evaluate the single dose PK of AZD5148.
Time frame: From Day 1 until last Follow up visit (Day 361 days)
Volume of distribution at terminal phase (IV administration only) (Vz)
To evaluate the single dose PK of AZD5148.
Time frame: From Day 1 until last Follow up visit (Day 361 days)
Systematic clearance (IV administration only) (CL)
To evaluate the single dose PK of AZD5148.
Time frame: From Day 1 until last Follow up visit (Day 361 days)
Apparent total body clearance (IM administration only) (CL/F)
To evaluate the single dose PK of AZD5148.
Time frame: From Day 1 until last Follow up visit (Day 361 days)
Apparent volume of distribution based on the terminal phase (IM administration only) (Vz/F)
To evaluate the single dose PK of AZD5148.
Time frame: From Day 1 until last Follow up visit (Day 361 days)
Bioavailability for extravascular administration (IM administration only) (F)
To evaluate the single dose PK of AZD5148.
Time frame: From Day 1 until last Follow up visit (Day 361 days)
Incidence of positive ADAs against AZD5148 in serum
To evaluate the ADA responses to a single IV or IM dose of AZD5148.
Time frame: Day 1 (pre-dose), Day 29, Day 91, Day 181 and Day 361