This is a Phase I Randomised Single-blind Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD9550 Following Single Ascending Dose Administration to Healthy Participants.
This study will be a Phase I, First-In-Human (FIH), randomised, single-blind, placebo-controlled, single ascending dose (SAD), sequential group study in healthy male and female participants of non- childbearing potential performed at a single study centre. The study consists of 3 parts: * Part A: SAD (up to 5 dose levels) of AZD9550 administered subcutaneous (SC) in healthy participants. * Part B: 1 dose level of AZD9550 administered SC in healthy participants of Japanese descent. * Part C: 1 dose level of AZD9550 administered intravenous (IV) in healthy participants. 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 2 days before (Day -2) investigational medicinal product (IMP\]) administration (Day 1) until at least 7 days (168 hours; Day 8) after IMP administration. * Weekly out-clinic visits on Days 15, 22, 29, and 36. * A Follow-up Visit 6 weeks (Day 43) after the IMP dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
Research Site
Harrow, United Kingdom
Adverse Events (AEs) and Serious Adverse Events (SAEs)
The safety and tolerability of AZD9550 following SC administration of single ascending doses to healthy participants, SC administration of a single dose to Japanese participants, and IV administration of a single dose to healthy participants will be assessed.
Time frame: Throughout the study (up to 6 months)
Area under concentration time curve from time 0 to infinity (AUCinf)
The AUCinf of AZD9550 following SC administration of single ascending doses to healthy participants, SC administration of a single dose to Japanese participants, and IV administration of a single dose to healthy participants will be assessed.
Time frame: Day 1 until Day 43 (follow-up visit)
Area under concentration-time curve from time 0 to the last quantifiable concentration (AUClast)
The AUClast of AZD9550 following SC administration of single ascending doses to healthy participants, SC administration of a single dose to Japanese participants, and IV administration of a single dose to healthy participants will be assessed.
Time frame: Day 1 until Day 43 (follow-up visit)
Maximum observed concentration (Cmax)
The Cmax of AZD9550 following SC administration of single ascending doses to healthy participants, SC administration of a single dose to Japanese participants, and IV administration of a single dose to healthy participants will be assessed.
Time frame: Day 1 until Day 43 (follow-up visit)
Incidence of Anti-Drug Antibodies (ADAs)
The immunogenicity of AZD9550 following SC and/or IV administration of AZD9550 will be assessed.
Time frame: Day 1 until Day 43 (follow-up visit)
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