New version of fabry drug tested against Brand-Name in healthy volunteers

NCT ID NCT05343715

Completed Knowledge-focused Sponsor: Bio Sidus SA Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

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.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

Fabry disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

FABRY DISEASE

Contacts and locations

Locations

Sanatorio Nuestra Señora del Pilar

Ciudadela, Buenos Aires, 1702, Argentina

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