Anifrolumab for Healthy Participants Study

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Research Site, Harrow, United Kingdom
Healthy Participants Study
Anifrolumab - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
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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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Healthy Participants Study

Study Objectives

3 Primary · 8 Secondary · Reporting Duration: Screening period (Day -28 to Day-2) through follow-up visit (Day 57) and evaluation of injection site reaction (Days 1 to 3)

Day 57
Apparent total body clearance of drug after extravascular administration (CL/F)
Apparent volume of distribution following extravascular administration (based on terminal phase) (Vz/F)
Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz)
Mean residence time of the unchanged drug in the systemic circulation from zero to infinity (MRT)
Time of last quantifiable concentration (tlast)
Time to reach peak or maximum observed concentration (tmax)
Day 1
Number of participants with positive Anti-drug antibodies (ADA)
Day 57
Number of participants with adverse events and serious adverse events
Up to Day 57
Area under serum concentration-time curve from time zero extrapolated to infinity (AUCinf)
Area under serum concentration-time curve from time zero to last quantifiable concentration (AUClast)
Maximum observed serum (peak) drug concentration (Cmax)

Trial Safety

Safety Progress

1 of 3

Other trials for Healthy Participants Study

Trial Design

2 Treatment Groups

Anifrolumab administered using APFS
1 of 2
Anifrolumab administered using AI
1 of 2
Active Control
Experimental Treatment

180 Total Participants · 2 Treatment Groups

Primary Treatment: Anifrolumab · No Placebo Group · Phase 1

Anifrolumab administered using AIExperimental Group · 2 Interventions: Anifrolumab, Autoinjector · Intervention Types: Drug, Device
Anifrolumab administered using APFSActiveComparator Group · 2 Interventions: Anifrolumab, Accessorized Pre-Filled Syringe · Intervention Types: Drug, Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anifrolumab
2015
Completed Phase 3
~1810
Autoinjector
2016
Completed Phase 3
~260

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: screening period (day -28 to day-2) through follow-up visit (day 57) and evaluation of injection site reaction (days 1 to 3)
Closest Location: Research Site · Brooklyn, MD
Photo of maryland 1Photo of maryland 2Photo of maryland 3
1900First Recorded Clinical Trial
1 TrialsResearching Healthy Participants Study
2957 CompletedClinical Trials

Who is running the clinical trial?

ParexelIndustry Sponsor
265 Previous Clinical Trials
94,774 Total Patients Enrolled
AstraZenecaLead Sponsor
3,935 Previous Clinical Trials
91,865,336 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are female and of childbearing potential.
Female participants of childbearing and non-childbearing potential and male participants must adhere to the contraception methods.
You are eligible for the study if you are aged 18 years or older and are willing to undergo the study procedures.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.