The study will evaluate the safety, tolerability, and the pharmacokinetics (PK) of AZD7503 following multiple subcutaneous doses in healthy Japanese participants.
This is a Phase I, randomised, single-blind, placebo-controlled study. The healthy Japanese participants will receive randomly (3:1) either AZD7503 or placebo subcutaneously. The study will comprise of: * A screening period of 28 days. * Randomization on Day 1. * A 9-week Treatment Period. Dose 1 will be administered on Day 1. Dose 2 will be administered at the study site on Day 29. Dose 3 will be administered on Day 57. * A follow-up period of 10 week after last dose of study intervention. * The total duration of the study will be 23 weeks
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
12
Research Site
Sumida-ku, Japan
Number of participants with adverse events
The safety and tolerability after multiple doses of AZD7503 in healthy Japanese participants will be evaluated.
Time frame: From Screening (Day -28) until Follow-up Day 127 (10 weeks post last dose)
Maximum plasma drug concentration (Cmax)
The Cmax after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated.
Time frame: Day 1, Day 2, Day 3, Day 5, Day 15, Day 29, Day 57, Day 58, and Day 59
Are under plasma concentration-time curve from time 0 to the last quantifiable concentration (AUClast)
The AUClast after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated.
Time frame: Day 1, Day 2, Day 3, Day 5, Day 15, Day 29, Day 57, Day 58, and Day 59
Area under plasma concentration-time curve from time 0 to infinity (AUCinf)
The AUCinf after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated.
Time frame: Day 1, Day 2, Day 3, Day 5, Day 15, Day 29, Day 57, Day 58, and Day 59
Area under plasma concentration-time curve during a dosing interval (AUCtau)
The AUCtau after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated.
Time frame: Day 1, Day 2, Day 3, Day 5, Day 15, Day 29, Day 57, Day 58, and Day 59
Amount of analyte excreted into the urine (Ae)
The Ae after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated.
Time frame: Day 1, Day 2, Day 3, Day 58, and Day 59
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Fraction of the dose excreted unchanged in urine (Fe)
The Fe after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated.
Time frame: Day 1, Day 2, Day 3, Day 58, and Day 59
Plasma concentration of AZD7503
The plasma concentration after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated.
Time frame: Day 1, Day 2, Day 3, Day 58, and Day 59
Plasma concentration of unconjugated antisense oligonucleotide (ASO)
The plasma concentration of unconjugated ASO at specified timepoints after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated.
Time frame: Day 1, Day 2, Day 3, Day 58, and Day 59