This study will evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of AZD5055 after single and multiple doses, orally administered in healthy Japanese and Chinese participants.
The study will be conducted in 2 parts: 1. Part 1 in single ascending dose (SAD) 2. Multiple dose Eligible Japanese and Chinese participants will be randomized to receive oral dose of either AZD5055 or placebo. The study will comprise of: * A Screening Period of maximum 28 days. * A Treatment Period during which participants will be resident at the Clinical Unit from the day before investigational medicinal product (IMP) administration until at least 72 hours after IMP administration. * A Follow-up Visit within 7 ± 1 (for Part 1) and 15 ± 1 (for Part 2) days after the last IMP dose. For the SAD part of the study, each participant will be involved in the study for 5 to 6 weeks. For the multiple dose part of the study, each participant will be involved in the study for 7 to 8 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
38
Research Site
Glendale, California, United States
Number of participants with adverse events
The safety and the tolerability after single and multiple doses of AZD5055 in healthy Japanese and Chinese participants will be evaluated.
Time frame: Until Follow-up (Day 7 ± 1 for Part 1 and Day 15 ± 1 for Part 2).
Maximum serum concentration (Cmax)
The Cmax after administration of single and multiple doses of AZD5055 in healthy Japanese and Chinese participants will be evaluated.
Time frame: Day 1 to Day 3 (Part 1) and Day 1 to Day 10 (Part 2)
Area under plasma concentration-time curve from time 0 to infinity (AUCinf)
The AUCinf after administration of single and multiple doses of AZD5055 in healthy Japanese and Chinese participants will be evaluated.
Time frame: Day 1 to Day 3 (Part 1) and Day 1 to Day 10 (Part 2)
Area under plasma concentration-curve from time 0 to the last quantifiable concentration (AUClast)
AUClast after administration of single and multiple doses of AZD5055 in healthy Japanese and Chinese participants will be evaluated.
Time frame: Day 1 to Day 3 (Part 1) and Day 1 to Day 10 (Part 2)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.