Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

A Randomized, Double-blind, Controlled, Parallel-group, Single Dose, Three arm Study to Compare the Pharmacokinetic Similarity of MAB-22 Versus Prolia® Sourced from the European Union and United States in Healthy Male Participants

This research study is comparing a new medication, MAB-22, with an existing one called Prolia®. Both medicines are used for conditions affecting your bones. The main goal is to find out if MAB-22 is handled by the body in the same way as Prolia®. To do this, healthy men will be asked to take a single dose of either MAB-22 or Prolia®. We will then carefully measure how the medicine moves through their body. This is a very early stage study, often called a Phase I study, where we check the basic science of how medicines work. It helps us understand if new medicines are similar enough to approved ones.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Xentria Inc.

Enrolment target

225

Start

30 May 2024

Healthy volunteers

What is this study about?

Imagine you have a known medicine that works well, but a pharmaceutical company wants to create a very similar, new version. This new version, let's call it MAB-22 for this study, needs to show that it behaves in your body just like the original, approved medicine (Prolia®).

This study is all about checking this similarity. We want to see if MAB-22 is absorbed, processed, and cleared from the body in the same way as Prolia®. This is really important because if they act the same way in the body, it means they might have similar effects for patients. Think of it like comparing two different brands of a common painkiller – you expect them to work in a similar way.

This type of study is called a 'bioequivalence' study. It helps ensure that new versions of medicines are just as effective and safe as the original. By understanding how MAB-22 works in healthy individuals, researchers can gather important information before potentially testing it in people who have bone conditions where such a medicine would be used.

Key takeaways

This study compares a new medicine (MAB-22) with an existing one (Prolia®).
It aims to see if MAB-22 works similarly in the body to Prolia®.
Only healthy men aged 18 and over can participate.
Participants will receive a single dose of one of the medicines.
Blood samples will be taken to track how the medicine moves through the body.
This is an early-stage study to gather basic information about the new medicine.

Who may be eligible?

To be part of this study, you need to be a healthy man, aged 18 years or older. This means you should generally be in good health and not have any ongoing medical conditions that might affect how your body handles the medicine.

The study focuses specifically on men to simplify the initial testing and understand the basic way the medicine works without other factors potentially affecting the results. There are likely other health requirements not mentioned in this brief summary, which a study doctor would discuss with you in full detail.

It's important to remember that 'healthy' in a research study often has a very specific meaning, and not everyone who feels healthy will qualify. This is to make sure the study results are as clear and reliable as possible.

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 a man?
Are you 18 years old or older?
Do you consider yourself in good health?
Are you generally free from serious ongoing medical conditions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive a single dose of either the investigational medicine (MAB-22) or the existing medicine (Prolia®). You wouldn't know which one you're getting, and neither would the study team, to keep the results fair.

Before and after taking the medicine, you would have several visits to the study clinic. During these visits, the medical team would take blood samples to measure how the medicine moves through your body over time. They would also monitor your general health and check for any changes or side effects. The exact number of visits and the total duration aren't specified here, but you'd be given a detailed schedule explaining everything before you decide to join.

Potential risks and benefits

Taking part in any study has potential benefits and risks. For this study, potential benefits might include contributing to medical science and helping develop new medicines. There isn't a direct health benefit for participants, as this is a study in healthy volunteers. Potential risks could include discomfort from blood draws, possible side effects from the medication (even though it's given as a single dose), and the time commitment required. All potential risks will be fully explained before you agree to participate, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

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

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Unverified
Hungary
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Unverified
Netherlands

Common questions

What does 'healthy volunteers' mean in this study?

It means participants should generally be in good health and not have any major ongoing medical conditions that could interfere with the study results.

Why are only men included in this study?

Scientists sometimes limit studies to one gender in the early stages to simplify the research and get a clearer picture of how a medicine works in the body.

What is Prolia®?

Prolia® is an existing medicine used to treat certain bone conditions, like osteoporosis.

Will I know which medicine I'm getting?

No, this is a 'double-blind' study, meaning neither you nor the study team will know if you're receiving MAB-22 or Prolia®. This helps ensure the results are unbiased.

What is a 'Phase I' or 'Human Pharmacology' study?

This is an early stage of clinical research where a new medicine is tested in a small group of healthy people to understand how it behaves in the body and if it's safe.