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

NCT05339100 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2023-05-11

No results posted yet for this study

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.

Conditions

  • Healthy Participants Study

Interventions

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.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-22
Primary Completion
2023-04-13
Completion
2023-04-13
FDA Drug
Yes

Countries

  • United States
  • Germany
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05339100 on ClinicalTrials.gov