New version of fabry drug tested against Brand-Name in healthy volunteers
NCT ID NCT05343715
First seen Nov 01, 2025 · Last updated Jun 19, 2026 · Updated 27 times
Summary
This early study tested whether a new version of the enzyme replacement drug agalsidase beta (made by Biosidus) works similarly to the approved drug Fabrazyme. Twenty-four healthy men received a single infusion of one of the two drugs. Researchers measured how the drug moved through the body and its enzyme activity to see if the new version could be a potential alternative for treating Fabry disease.
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This is a summary of
the original study
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Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Contacts and locations
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Locations
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Sanatorio Nuestra Señora del Pilar
Ciudadela, Buenos Aires, 1702, Argentina
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
agalsidase beta (enzyme replacement therapy)
What this could lead to
If the new formulation works similarly to Fabrazyme, it could offer an alternative treatment option for Fabry disease.
What could go wrong
This is a very early, small study in healthy volunteers, not Fabry patients. It only tests a single dose, so it cannot predict long-term safety or effectiveness.
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.