The purpose of the study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AZD1043 following single and multiple ascending doses in healthy adult participants living with overweight and/or obesity, including participants of Japanese and Chinese descent.
This is a phase 1, first time in human (FTiH) randomized, single-blind, placebo-controlled study in healthy male and female participants living with overweight and/or obesity, with female participants being of non-childbearing potential. It consists of 2 parts: Part A (single ascending doses: SAD): This will consist of Part A1 (Global SAD (GSAD)) with 6 cohorts, Part A2 (Japanese SAD (JSAD)) with 2 cohorts and Part A3 (Chinese SAD (CSAD)) with 1 cohort. Part B (multiple ascending doses: MAD): This will consist of Part B1 (Global MAD (GMAD)) with 3 cohorts and Part B2 (Japanese MAD (JMAD)) with 1 cohort. Participants are only allowed to participate in one of the cohorts. Both Part A and Part B will comprise of: * Screening period (up to 5 weeks). * Treatment period. * Safety follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
104
Research Site
Glendale, California, United States
RECRUITINGResearch Site
Harrow, United Kingdom
NOT_YET_RECRUITINGNumber of participants with adverse events (AEs), serious adverse events (SAEs), AE leading to discontinuation (DAEs), and AEs of special interest (AESIs)
To assess the safety and tolerability of a single or multiple doses of AZD1043 in healthy adult participants living with overweight and/or obesity, including participants of Japanese and Chinese descent.
Time frame: Part A (SAD): From Day-35 to Day 253; Part B (MAD): From Day 1 to Day 253
Area under concentration-time curve from time 0 to infinity (AUCinf) (Part A only)
To characterize the PK of a single or multiple doses of AZD1043 in healthy adult participants living with overweight and/or obesity, including participants of Japanese and Chinese descent.
Time frame: From Day 1 to Day 253
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
To characterize the PK of a single or multiple doses of AZD1043 in healthy adult participants living with overweight and/or obesity, including participants of Japanese and Chinese descent.
Time frame: From Day 1 to Day 253
Maximum observed drug concentration (Cmax)
To characterize the PK of a single or multiple doses of AZD1043 in healthy adult participants living with overweight and/or obesity, including participants of Japanese and Chinese descent.
Time frame: From Day 1 to Day 253
AstraZeneca Clinical Study Information Center
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