Active not recruitingPHASE1INTERVENTIONAL

Safety, PK/PD, and Immunogenicity Study of SC ALXN2030 in Healthy Participants

This research study is testing a new medicine, ALXN2030, which is given as an injection under the skin. The main goal is to find out if it's safe for healthy people and what side effects it might cause, especially at different doses. We also want to understand how the medicine moves through and is used by the body. This is a very early study, called a Phase 1 trial, meaning it's one of the first times this medicine is being tested in humans. Participants will either receive ALXN2030 or a dummy injection (placebo). Your involvement would help us learn vital information to potentially develop new treatments in the future.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Alexion Pharmaceuticals, Inc.

Enrolment target

Start

16 Aug 2022

Estimated completion

14 Oct 2026

Healthy

What is this study about?

This study is looking at a new investigational medication called ALXN2030. When we say 'investigational,' it means it's still being tested and is not yet approved as a treatment. The main purpose of this research is to understand if ALXN2030 is safe for people and what its possible side effects might be. We're also interested in how the body processes the medicine and how it affects different bodily functions.

This is a 'Phase 1' study, which is the earliest stage of human testing for a new medicine. In these studies, we usually involve healthy volunteers so we can carefully monitor how the new medicine behaves without interference from other health conditions. Learning about the safety of ALXN2030 in healthy people is a crucial first step before it can be studied in people with specific illnesses.

Some participants will receive the actual medicine, ALXN2030, while others will receive a 'placebo.' A placebo looks just like the real medicine but contains no active ingredients. This helps researchers accurately compare the effects of the new medicine against no treatment at all, ensuring we can really tell what effects are caused by ALXN2030.

Key takeaways

This is an early-stage study (Phase 1) of a new medicine called ALXN2030.
The main goal is to check the medicine's safety and how it behaves in healthy people.
Participants will receive either the study medicine or a dummy injection.
Your health will be closely monitored with various tests and check-ups.
Your participation helps advance medical research, but there's no direct personal health benefit.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be a healthy adult, generally between 18 and 60 years old. If you are of Japanese background (meaning both your parents and all four grandparents were Japanese), you must be between 20 and 60 years old. Your general health will be checked, including your heart activity (through an ECG, which measures electrical signals in your heart) and your Body Mass Index (BMI), which is a measure of healthy weight for your height. For this study, your BMI should be between 18 and 32.

There are certain reasons why you might not be able to join. For example, if you have any serious current or ongoing health conditions, either physical or mental, you won't be able to take part. This also applies if you've had major surgery or been in hospital within the past 3 months. Safety is our top priority, so if the study doctor thinks it might put you at risk, you wouldn't be able to join.

Also, if you are pregnant or breastfeeding, you cannot participate. If you have ever had an allergic reaction to similar types of medicines or any of the ingredients in ALXN2030, you also wouldn't be eligible. The study team will carefully review your medical history to make sure it's safe for you to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 60 years old (or 20 and 60 if of Japanese descent)?
Do you consider yourself generally healthy?
Do you have a healthy weight for your height (BMI between 18 and 32)?
Are you NOT pregnant or breastfeeding?
Have you NOT had major surgery or been in hospital in the last 3 months?
Are you NOT allergic to similar medicines or any ingredients in ALXN2030?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be in the study for a short period. First, there will be screening visits to check if you are eligible based on your health and medical history. Once you're accepted, you'll stay overnight at the study clinic at specific times. During these visits, you'll receive either the study medication (ALXN2030) or a placebo as an injection under your skin.

Throughout the study, you'll have various check-ups, which include physical exams, blood and urine tests, and heart tracings (ECGs). These are done to monitor your health and see how you're reacting to the medication. After receiving the dose, there will be follow-up visits to ensure your well-being and to collect more information. The total length of your participation, from initial screening to your final check-up, will be explained in detail by the study team.

Potential risks and benefits

The main benefit of participating in this study is contributing to medical research and helping scientists understand a new potential medicine. While there might not be a direct health benefit to you as a healthy participant, your involvement is crucial for potentially developing future treatments for others. As with any medication, there are potential risks, including side effects from the study drug or the procedures involved, like blood draws. These possible risks will be fully explained to you before you agree to take part. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Research Site
Verified postcode
Harrow, United Kingdom

Common questions

What is ALXN2030?

ALXN2030 is a new medicine being tested. It's not yet approved and we are studying its safety and how it works in the body.

Why is this study only for healthy people?

Phase 1 studies like this one often start with healthy volunteers. This helps us understand the medicine's basic safety and how the body handles it without other health conditions making things complicated.

Will I get the actual medicine or a dummy injection?

You will either receive the actual medicine (ALXN2030) or a dummy injection (placebo). You won't know which one you receive until after the study is over, as this helps researchers get accurate results.

How will I receive the injection?

The study medication or placebo will be given as an injection just under your skin, similar to some common vaccinations.

How long will I be involved in the study?

The total time you spend in the study, including screening, overnight stays, and follow-up visits, will be fully explained by the study team before you decide to join.