NCT05339100

Accessorized Pre-Filled Syringe to Autoinjector Pharmacokinetic Bridging Study in Anifrolumab

A Multicenter, Randomized, Open-label, Parallel Phase 1 Comparability Study of Anifrolumab Administered Using Accessorized Pre-Filled Syringe (APFS) or Autoinjector (AI) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will be conducted to compare the pharmacokinetic (PK) exposure after a single SC dose of anifrolumab administered using an AI with the PK exposure after a single subcutaneous (SC) dose of anifrolumab administered using APFS in healthy male and female volunteers.

Detailed description

This will be a multicenter, randomized, open-label, parallel group Phase 1 study. After meeting the eligibility criteria, all eligible participants will be randomized 1:1:1:1:1:1 to a device group (APFS or AI) for an anatomical injection site as defined in the protocol. Randomization will be stratified by protocol defined body weight categories and clinical unit. The study will comprise: * A Screening Period up to 28 days. * One treatment period during which eligible participants will be admitted to the Clinical Unit on Day -1 to reassess their eligibility. Participants who meet eligibility criteria will be randomized to receive a single subcutaneous (SC) dose of anifrolumab by either APFS or AI device on Day 1. Participants will be discharged on Day 3. * The participants will return to the center for Follow-up Visits on Days 6, 8, 12, 15, 22, 29, and 43. * A final Follow-up Visit on Day 57.

Conditions

• Healthy Participants Study

Interventions

Type	Name	Description
DRUG	Anifrolumab	Participants will receive SC doses anifrolumab via AI or APFS.
DEVICE	Autoinjector	Autoinjector will be use to administer single SC dose of anifrolumab.
DEVICE	Accessorized Pre-Filled Syringe	Accessorized Pre-filled syringe will be use to administer single SC dose of anifrolumab.

Timeline

• Start date: 2022-03-22
• Primary completion: 2023-04-13
• Completion: 2023-04-13
• First posted: 2022-04-21
• Last updated: 2023-05-11

Locations

3 sites across 3 countries: United States, Germany, United Kingdom

Regulatory

• FDA-regulated drug study