A study to demonstrate the safety and tolerability of AZD1163 when administered intravenously and subcutaneously in healthy participants.
This is a first time in human (FTiH), placebo-controlled, sequential study in healthy participants. This study consists of two parts: Part 1 Single Ascending Dose (SAD) and Part 2 Multiple Ascending Dose (MAD). Part 1 will contain 9 cohorts, 8 intravenously (IV) administered dose levels and 1 subcutaneously (SC) administered dose level of AZD1163. Part 2 will contain 2 SC dose levels of AZD1163. A sentinel dosing approach will be taken. Each participant will be involved in the study for approximately 70 weeks. The study will comprise of: * A Screening Period of maximum 28 days for both Part 1 and Part 2. * Part 1: A single dose of AZD1163 with an in-clinic period of 7 to 8 days. * Part 2: Two doses of AZD1163, given 2 weeks apart both with an in-clinic period of 7 to 8 days. * An outpatient Follow-up Period of approximately 15 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
108
In Part 1, Participants will receive AZD1163 through IV infusion or SC injection on Day 1. In Part 2, participants will receive AZD1163 through SC injection on Days 1 and 15.
In Part 1, Participants will receive matching placebo through IV infusion or SC injection on Day 1. In Part 2, participants will receive matching placebo through SC injection on Days 1 and 15.
Research Site
Glendale, California, United States
Research Site
Brooklyn, Maryland, United States
Research Site
Berlin, Germany
Number of participants with adverse events (AEs)
To assess the safety and tolerability of single and multiple ascending doses of AZD1163 following IV or SC administration.
Time frame: From Day -1 until end of study (Day 450)
Area under plasma concentration-time curve from zero extrapolated to infinity (AUCinf)
To characterize the pharmacokinetics (PK) of AZD1163 following IV/SC administration of single and multiple ascending doses.
Time frame: Part 1: Days 1-8, 11, 15, 22, 29, 57, 113, 225, 281, 365, 450; Part 2: Days 1-8, 11, 15-16, 22, 29, 57, 113, 225, 281, 365, 450
Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast)
To characterize the PK of AZD1163 following IV/SC administration of single and multiple ascending doses.
Time frame: Part 1: Days 1-8, 11, 15, 22, 29, 57, 113, 225, 281, 365, 450; Part 2: Days 1-8, 11, 15-16, 22, 29, 57, 113, 225, 281, 365, 450
Apparent total body clearance of drug from plasma after extravascular administration (CL/F)
To characterize the PK of AZD1163 following SC administration of single and multiple ascending doses.
Time frame: Part 1: Days 1-8, 11, 15, 22, 29, 57, 113, 225, 281, 365, 450; Part 2: Days 1-8, 11, 15-16, 22, 29, 57, 113, 225, 281, 365, 450
Volume of distribution (apparent) at steady state following extravascular administration (Vz/F)
To characterize the PK of AZD1163 following SC administration of single and multiple ascending doses.
Time frame: Part 1: Days 1-8, 11, 15, 22, 29, 57, 113, 225, 281, 365, 450; Part 2: Days 1-8, 11, 15-16, 22, 29, 57, 113, 225, 281, 365, 450
Maximum observed plasma (peak) drug concentration (Cmax)
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To characterize the PK of AZD1163 following IV/SC administration of single and multiple ascending doses.
Time frame: Part 1: Days 1-8, 11, 15, 22, 29, 57, 113, 225, 281, 365, 450; Part 2: Days 1-8, 11, 15-16, 22, 29, 57, 113, 225, 281, 365, 450
Number of participants with positive anti-AZD1163 antibodies
To evaluate the immunogenicity of AZD1163.
Time frame: Part 1: Day 1, 11, 29, 113, 225, 281, 365, 450; Part 2: Day 1, 15, 29, 57, 113, 281, 365, 450