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Monoclonal Antibodies

Anifrolumab for Healthy Participants

Phase 1
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening period (day -28 to day-2) through follow-up visit (day 57) and evaluation of injection site reaction (days 1 to 3)
Awards & highlights

Study Summary

This trial will compare how well two ways of giving the drug anifrolumab work in healthy male and female volunteers.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening period (day -28 to day-2) through follow-up visit (day 57) and evaluation of injection site reaction (days 1 to 3)
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening period (day -28 to day-2) through follow-up visit (day 57) and evaluation of injection site reaction (days 1 to 3) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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)
Secondary outcome measures
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)
+5 more

Side effects data

From 2018 Phase 3 trial • 373 Patients • NCT02446899
23%
Upper respiratory tract infection
16%
Nasopharyngitis
14%
Infusion related reaction
13%
Bronchitis
12%
Urinary tract infection
7%
Herpes zoster
7%
Sinusitis
6%
Cough
6%
Headache
6%
Back pain
6%
Arthralgia
4%
Nausea
2%
Pneumonia
1%
Angioedema
1%
Hypoaesthesia
1%
Cervical dysplasia
1%
Acute coronary syndrome
1%
Chilaiditi's syndrome
1%
Hypersensitivity
1%
Appendicitis
1%
Diverticulitis
1%
Gastroenteritis viral
1%
Lip squamous cell carcinoma
1%
Fall
1%
Nephrolithiasis
1%
Traumatic fracture
1%
Blood creatinine increased
1%
Osteonecrosis
1%
Systemic lupus erythematosus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anifrolumab 300 mg
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Anifrolumab administered using AIExperimental Treatment2 Interventions
Randomized participants will receive a single SC dose of anifrolumab via AI.
Group II: Anifrolumab administered using APFSActive Control2 Interventions
Randomized participants will receive a single SC dose of anifrolumab via APFS.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anifrolumab
2015
Completed Phase 3
~1990
Autoinjector
2016
Completed Phase 3
~440

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,260 Previous Clinical Trials
288,593,972 Total Patients Enrolled
ParexelIndustry Sponsor
303 Previous Clinical Trials
100,646 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of participants enrolled in this experiment?

"Affirmative. According to clinicaltrials.gov, this research project is still actively seeking out participants since its initial posting on March 22nd 2022 and last edit occurring on November 23rd 2022. 180 people need be enrolled from one site."

Answered by AI

What are the primary objectives of this clinical experiment?

"As per AstraZeneca, the primary outcome being assessed over a 57-day period is Area under serum concentration-time curve from time zero extrapolated to infinity (AUCinf). The secondary outcomes that will also be measured include Half-life associated with terminal slope (λz), Mean residence time of the unchanged drug in systemic circulation from zero to infinity (MRT) and Time of last quantifiable concentration (tlast). These parameters are defined as evaluations of anifrolumab administered at various anatomical injection sites and within different body weight ranges."

Answered by AI

Could I be a suitable candidate for this research program?

"This trial seeks 180 participants who meet the criteria of being between 18 and 55 years old, with no prior medical conditions."

Answered by AI

Does this clinical experiment accept individuals aged eighteen or older?

"As specified in the study's eligibility criteria, prospective participants must be between 18 and 55 years old."

Answered by AI

Are there any potential risks associated with Anifrolumab treatment?

"As this is an early-phase trial, the safety of Anifrolumab was evaluated as a 1 due to limited clinical data."

Answered by AI

Are there any opportunities for recruitment into this research experiment?

"Affirmative. According to the information on clinicaltrials.gov, this study is currently looking for participants and was initially posted in March of 2022 with its most recent revision occurring November 23rd of that same year. The trial requires 180 patients at 1 site to complete enrolment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Accessorized Pre-Filled Syringe to Autoinjector Pharmacokinetic Bridging Study in Anifrolumab
2022. "Accessorized Pre-Filled Syringe to Autoinjector Pharmacokinetic Bridging Study in Anifrolumab". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05339100.
~58 spots leftby Apr 2025
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