This is a dose exploration study to evaluate the safety and pharmacokinetics (PK) of AZD3152 in healthy adult male and female participants, across different dose levels and routes of administration (ie, Intramuscular \[IM\] injection and Intravenous \[IV\] infusion).
The study will be conducted in the United States of America. Eligible healthy participants will be randomized to receive either AZD3152 or placebo administered IM or IV, across 5 fixed-dose cohorts. Participants will receive a single dose of AZD3152/placebo. Cohort 1: Dose X of AZD3152 or placebo, as an IM injection Cohort 2: Dose X of AZD3152 or placebo, administered IV Cohort 3: Dose Y of AZD3152 or placebo, as an IM injection Cohort 4: Dose Y of AZD3152 or placebo, administered IV Cohort 5: Dose Z of AZD3152 or placebo, administered IV The study will comprise of: * A Screening Period of maximum 28 days. * A Treatment Period of one Day. * A Follow-up Period of 12 months after study intervention (Day 365).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
98
Research Site
Anniston, Alabama, United States
Research Site
Cullman, Alabama, United States
Research Site
Scottsdale, Arizona, United States
Research Site
Orlando, Florida, United States
Number of participants with adverse event
Evaluation of the safety of IM or IV administration of AZD3152 will be done.
Time frame: Until Day 91
Number of participants with serious adverse event
Evaluation of the safety of IM or IV administration of AZD3152 will be done.
Time frame: Until Day 365 or early discontinuation visit (EDV [approximately 19 months])
Number of participants with adverse event of special interest
Evaluation of the safety of IM or IV administration of AZD3152 will be done.
Time frame: Until Day 365 or EDV (approximately 19 months)
Serum concentration of AZD3152
Pharmacokinetics (PK) characterization of AZD3152 in serum after a single IM or IV dose.
Time frame: Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)
Maximum observed concentration (Cmax) of AZD3152
PK (Cmax) characterization of AZD3152 in serum after a single IM or IV dose.
Time frame: Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)
Time to reach maximum observed concentration (tmax) of AZD3152
PK (tmax) characterization of AZD3152 in serum after a single IM or IV dose.
Time frame: Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)
Terminal elimination half-life (t1/2) of AZD3152
PK (t1/2) characterization of AZD3152 in serum after a single IM or IV dose.
Time frame: Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)
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Area under the serum concentration-curve from 0 to the last quantifiable concentration (AUClast) of AZD3152
PK (AUClast) characterization of AZD3152 in serum after a single IM or IV dose.
Time frame: Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)
Area under concentration-time curve from 0 to infinity (AUCinf) of AZD3152
PK (AUCinf) characterization of AZD3152 in serum after a single IM or IV dose.
Time frame: Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)
Apparent total body clearance (CL/F) of AZD3152 (IM administration only)
PK (CL/F) characterization of AZD3152 in serum after a single IM.
Time frame: Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)
Apparent volume of distribution based on terminal phase (Vz/F) of AZD3152 (IM administration only)
PK (Vz/F) characterization of AZD3152 in serum after a single IM.
Time frame: Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)
Total body clearance (CL) of AZD3152 (IV administration only)
PK (CL) characterization of AZD3152 in serum after a single IV.
Time frame: Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)
Volume of distribution based on terminal phase (Vz) of AZD3152 (IV administration only)
PK (Vz) characterization of AZD3152 in serum after a single IV.
Time frame: Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)
Volume of distribution at steady state (Vss) of AZD3152 (IV administration only)
PK (Vss) characterization of AZD3152 in serum after a single IV.
Time frame: Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)
Number of participants with anti-drug antibody (ADA) to AZD3152
Evaluation of ADA responses to AZD3152.
Time frame: Pre-dose, Days 15, 31, 91, 181, and Day 365