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Gefurulimab PFS-SD for Healthy Adults

Phase 1
Recruiting
Research Sponsored by Alexion Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants who are healthy as determined by medical evaluation with no clinically significant or relevant abnormalities as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluation.
Documented vaccination against meningococcal infection from serogroups A, C, W, and Y and serogroup B.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, day 92
Awards & highlights

Study Summary

This trial will test a drug called gefurulimab to see how it is processed in the body, how it affects the body, if it is safe to use, if it causes any immune

Who is the study for?
This trial is for healthy adults who want to participate in a study evaluating gefurulimab, a medication delivered either by an autoinjector (AI) or prefilled syringe with single-dose (PFS-SD). Specific eligibility criteria are not provided.Check my eligibility
What is being tested?
The study is testing the delivery of gefurulimab using two methods: an autoinjector and a prefilled syringe. It aims to compare how the body processes the drug, its effects on the body, safety profiles, potential for immune response, and how well each device works.See study design
What are the potential side effects?
Since this trial involves healthy participants and specific side effects are not listed, it's expected that any common side effects would be monitored as part of the trial's safety assessment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am healthy with no significant medical issues as confirmed by recent tests and exams.
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I am vaccinated against meningococcal infection (A, C, W, Y, B).
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I am between 18 and 65 years old.
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My weight is between 50 and 110 kg, and my BMI is between 18.5 and 30.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, day 92
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 92 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 the serum concentration-time curve from time zero to the last measurable concentration (AUClast)
Area under the serum concentration-time curve from time zero to time infinity (AUCinf)
Maximum (peak) concentration observed after study intervention administration (Cmax)
Secondary outcome measures
Apparent total body clearance of the study intervention from serum (CL/F)
Apparent volume of distribution (Vd/F)
Incidence of antidrug antibody (ADA) to gefurulimab category of immune-response and titer
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Gefurulimab PFS-SDExperimental Treatment1 Intervention
Participants will be administered gefurulimab as a single dose of 600 mg by PFS-SD on the abdomen, thigh, or upper arm.
Group II: Gefurulimab AIExperimental Treatment1 Intervention
Participants will be administered gefurulimab as a single dose of 600 mg by AI on the abdomen, thigh, or upper arm.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Alexion Pharmaceuticals, Inc.Lead Sponsor
253 Previous Clinical Trials
41,028 Total Patients Enrolled
ParexelIndustry Sponsor
304 Previous Clinical Trials
100,978 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 primary objective of this medical study?

"The main objective of this trial, to be evaluated from Day 1 until early discontinuation or Day 92, is the Area under the serum concentration-time curve from time zero to time infinity (AUCinf). The secondary outcomes include assessing Terminal elimination half-life (t½) in healthy participants across devices and injection sites for gefurulimab SC. Additionally, Serum free C5 concentrations will be assessed in healthy participants across devices and injection sites for gefurulimab SC. Lastly, Time to maximum observed serum concentration (tmax) will also be evaluated in healthy participants across devices and injection sites for gefurulimab"

Answered by AI

Are patients currently being actively recruited for participation in this trial?

"According to the available information on clinicaltrials.gov, this research study is actively seeking eligible participants. The trial was first posted on November 22nd, 2023 and underwent its most recent update on January 5th, 2024."

Answered by AI

What are the eligibility criteria for participating in this clinical trial?

"To be eligible for enrollment in this research study, interested individuals must meet the criteria of being healthy adults aged between 18 and 65 years old. Approximately 174 participants will have the opportunity to participate in this investigation."

Answered by AI

Are participants of this research study required to be at least 20 years old?

"This medical research study is seeking individuals who are above the age of 18 and below the age of 65 to enroll as participants."

Answered by AI

Has the AI-based drug Gefurulimab received approval from the FDA?

"Based on our assessment, Gefurulimab AI received a safety rating of 1. Since this is a Phase 1 trial, there is limited data available to support both the safety and effectiveness of the treatment."

Answered by AI

What is the upper limit on the number of participants who can be enrolled in this medical study?

"Indeed, the information available on clinicaltrials.gov clearly states that this study is currently in the recruitment phase. The trial was initially posted on November 22nd, 2023 and recently updated on January 5th, 2024. There is a need to recruit a total of 174 patients from two designated sites for this clinical trial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Subcutaneous Gefurulimab Using Prefilled Syringe Versus Autoinjector in Healthy Adult Participants
2023. "A Study of Subcutaneous Gefurulimab Using Prefilled Syringe Versus Autoinjector in Healthy Adult Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06208488.
~116 spots leftby Apr 2025
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