NCT06103877

A Placebo-controlled Safety and Tolerability Study of Intravenous (IV) and Subcutaneous (SC) AZD1163 in Healthy Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A study to demonstrate the safety and tolerability of AZD1163 when administered intravenously and subcutaneously in healthy participants.

Detailed description

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	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.
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.

Timeline

• Start date: 2023-11-01
• Primary completion: 2026-01-13
• Completion: 2026-01-13
• First posted: 2023-10-27
• Last updated: 2026-01-27

Locations

3 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated drug study