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A Study of Subcutaneous Gefurulimab Using Prefilled Syringe Versus Autoinjector in Healthy Adult Participants

Comparing two injection methods for Gefurulimab in healthy adults.

Recruiting
18-65 years
All
Phase 1
Study Overview: This research is about how a medicine called gefurulimab, used for certain conditions, acts in the body. Researchers will see how it works when given using two different devices: a prefilled syringe (PFS-SD) or an autoinjector (AI). They will also check the medicine's safety and how your body reacts to it. Study Details: The study lasts up to 162 days. It starts with a screening period of about 70 days, where doctors make sure you are healthy enough to join. Then, there is an evaluation period of 92 days. During this time, you will get a single dose of gefurulimab on the first day and stay at the clinic until Day 5. After that, you will visit the clinic weekly until Day 50, then every two weeks until Day 92. Eligibility: To join, you should be between 18 and 65 years old, weigh between 50 kg and 110 kg, and be generally healthy. You cannot have certain medical conditions or allergies, and you must have certain vaccinations. Key Points: - *Total study duration is up to 162 days.* - *A single dose will be given, with several follow-up visits.* - *Participants must meet specific health criteria to join.*
Study details
    Healthy Adult Participants

NCT06208488

Alexion Pharmaceuticals, Inc.

24 January 2024

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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