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

Study identifier:D3465C00002

ClinicalTrials.gov identifier:NCT05339100

EudraCT identifier:2021-004896-14

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

Healthy Participants Study

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Anifrolumab

Sex

All

Actual Enrollment

180

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 22 Mar 2022
Primary Completion Date: 13 Apr 2023
Study Completion Date: 13 Apr 2023

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Other

Verification:

Verified 01 May 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Parexel International

Inclusion and exclusion criteria