A placebo-controlled safety and tolerability study of intravenous (IV) and subcutaneous (SC) AZD1163 in healthy volunteers
Study identifier:D9640C00001
ClinicalTrials.gov identifier:NCT06103877
EudraCT identifier:N/A
CTIS identifier:N/A
Recruiting
Official Title
A Phase I, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of AZD1163 Administered as Single and Multiple Ascending Doses in Healthy Volunteers
Medical condition
Healthy Volunteers
Phase
Phase 1
Healthy volunteers
Yes
Study drug
-
Sex
All
Estimated Enrollment
99
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 01 Nov 2023
Estimated Primary Completion Date: 03 Apr 2025
Estimated Study Completion Date: 27 Apr 2026
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Oct 2024 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
PAREXEL
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Part 1 Cohort 1 SAD Participants will receive IV infusion of AZD1163 on Day 1. | Biological/Vaccine: AZD1163 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. |
| Active Comparator: Part 1 Cohort 2 SAD Participants will receive IV infusion of AZD1163 on Day 1. | Biological/Vaccine: AZD1163 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. |
| Active Comparator: Part 1 Cohort 3 SAD Participants will receive IV infusion of AZD1163 on Day 1. | Biological/Vaccine: AZD1163 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. |
| Active Comparator: Part 1 Cohort 4 SAD Participants will receive IV infusion of AZD1163 on Day 1. | Biological/Vaccine: AZD1163 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. |
| Active Comparator: Part 1 Cohort 5a SAD Participants will receive IV infusion of AZD1163 on Day 1. | Biological/Vaccine: AZD1163 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. |
| Active Comparator: Part 1 Cohort 5b SAD Participants will receive SC injection of AZD1163 on Day 1. | Biological/Vaccine: AZD1163 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. |
| Active Comparator: Part 1 Cohort 6 SAD Participants will receive IV infusion of AZD1163 on Day 1. | Biological/Vaccine: AZD1163 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. |
| Active Comparator: Part 1 Cohort 7 SAD Participants will receive IV infusion of AZD1163 on Day 1. | Biological/Vaccine: AZD1163 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. |
| Active Comparator: Part 1 Cohort 8 SAD Participants will receive IV infusion of AZD1163 on Day 1. | Biological/Vaccine: AZD1163 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. |
| Placebo Comparator: Part 1 pooled Placebo SAD IV Participants will receive matching IV infusion of placebo on Day 1. | Other: Placebo 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. |
| Placebo Comparator: Part 1 pooled Placebo SAD SC Participants will receive matching SC injection of placebo on Day 1. | Other: Placebo 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. |
| Active Comparator: Part 2 Cohort 1 MAD (Japanese participants) Participants will receive SC injection of AZD1163 on Days 1 and 15. | Biological/Vaccine: AZD1163 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. |
| Active Comparator: Part 2 Cohort 2 MAD (Japanese participants) Participants will receive SC injection of AZD1163 on Days 1 and 15. | Biological/Vaccine: AZD1163 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. |
| Active Comparator: Part 2 Cohort 1 MAD (Chinese participants) Participants will receive SC injection of AZD1163 on Days 1 and 15. | Biological/Vaccine: AZD1163 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. |
| Active Comparator: Part 2 Cohort 2 MAD (Chinese participants) Participants will receive SC injection of AZD1163 on Days 1 and 15. | Biological/Vaccine: AZD1163 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. |
| Placebo Comparator: Part 2 Placebo MAD (Japanese participants) Participants will receive matching SC injection of placebo on Days 1 and 15. | Other: Placebo 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. |
| Placebo Comparator: Part 2 Placebo MAD (Chinese participants) Participants will receive matching SC injection of placebo on Days 1 and 15. | Other: Placebo 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. |
