This study will assess the safety, tolerability, and pharmacokinetic (PK) of AZD5462 following single ascending dose (SAD) and multiple ascending dose (MAD) administration in healthy male and female participants and healthy participants of Japanese descent.
This Phase I, First in Human (FIH), randomized single-blind, placebo-controlled study will consist of 2 parts (Part A and Part B) with an interleaved study design. Part A of the study will be a sequential SAD design with 5 dose levels planned to be investigated across 8 cohorts, of which 3 cohorts will solely comprise of participants of Japanese descent. Within each cohort, 6 participants will be randomized to receive AZD5462 and 2 participants randomized to receive placebo. Part B of the study will be a sequential MAD design with 4 dose levels of AZD5462 planned to be investigated across 5 cohorts, of which 1 cohort will comprise solely of participants of Japanese descent. Within each cohort 6 participants will be randomized to receive AZD5462 and 2 participants randomized to receive placebo. The duration for participants randomized to Part A of the study is 5 to 6 weeks, and for Part B, 6 to 7 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
98
Research Site
Glendale, California, United States
Number of Participants with Adverse Events
Assessment of the safety and tolerability of AZD5462 following administration of single ascending doses (Part A) and multiple ascending doses (Part B).
Time frame: Upto Follow-up (Part A: Day 10 ± 3; Part B: Day 19 ± 3)
Maximum observed plasma (peak) drug concentration (Cmax) for AZD5462
Characterization of the single dose and steady state PK of AZD5462 following administration.
Time frame: Part A: Day 1 (pre-dose and post-dose), and Days 2, 3, and 10 (post-dose); Part B: Days 1 to 19 (pre and post-doses)
Area under the plasma concentration curve from zero to the last quantifiable concentration (AUClast) for AZD5462
Characterization of the single dose and steady state PK of AZD5462 following administration.
Time frame: Part A: Day 1 (pre-dose and post-dose), and Days 2, 3, and 10 (post-dose); Part B: Days 1 to 19 (pre and post-doses)
Area under plasma concentration time curve from zero to infinity (AUCinf) for AZD5462
Characterization of the single dose and steady state PK of AZD5462 following administration.
Time frame: Part A: Day 1 (pre-dose and post-dose), and Days 2, 3, and 10 (post-dose); Part B: Days 1 to 19 (pre and post-doses)
Renal clearance of drug from plasma (CLR) for AZD5462
Characterization of the single dose and steady state PK of AZD5462 following administration.
Time frame: Part A: Day 1 (pre-dose and post-dose), and Days 2, 3, and 10 (post-dose); Part B: Days 1 to 19 (pre and post-doses)
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