PK/PD Study of 2 Agalsidase Formulations in Single Dose of 1 mg/kg Administered to Healthy Volunteers as IV Infusion

Exclusion Criteria

• •1. History of clinically significant allergies (except for untreated asymptomatic seasonal allergies)
• •2. A drop of ≥ 20 mmHg of systolic blood pressure or ≥ 10 mmHg of diastolic blood pressure within the first 3 minutes after the postural change
• •3. Volunteers who are receiving other drugs (prescription or over-the-counter) or who have within the 2 weeks prior to the study
• •4. Volunteers with history of autoimmune diseases.
• •5. Chronic disorders of the CNS, psychological and/or psychiatric disorders: bipolar disorder, severe depression, insomnia, changes in personality
• •6. Active or chronic infections
• •7. Having received live or inactivated viral or bacterial vaccines, within the fifteen days prior to visits 1 or 2
• •8. For COVID vaccines, a 15 day window period prior to visits #1 or #2 must be respected. This period was taken from the recommendations published by the National Ministry of Health on May 29th 2021. The volunteer will be able to receive the vaccine 35 days after receiving the investigational product.
• •9. Known allergies to any of the components of the formulations
• •10. Active smoker, of more than 10 cigarettes/day
• •11. Current clinical evidence of severe digestive disorders, surgeries of the gastrointestinal tract (except for appendectomy)
• •12. Current clinical evidence of kidney disease
• •13. Current clinical evidence of liver disorders
• •14. Current clinical evidence of respiratory and cardiac disease
• •15. Presence of diabetes mellitus, thyroid dysfunction or other endocrine disorders
• •16. Evidence of active gastroduodenal disease
• •17. History of peripheral thrombotic phenomena
• •18. Underlying neurological disease
• •19. Presence of a current progressive chronic disease
• •20. History of drug or alcohol abuse or addiction within the last three years
• •21. Participation in a clinical study within the last three months
• •22. Use of any drug within the fourteen days prior to the start of the study that, according to the principal investigator's judgement may interfere with the biodistribution of the medicinal product.
• •23. Subjects who have donated or suffered from blood loss within the twelve weeks prior to the start of the study, or intends to donate blood within the following three months after the completion of the study.
• •24. Excessive drinker of tea, cocoa, mate, coffee and/or caffeinated drinks (\>5 cups/day) or of wine (\>0.5 L/day) or alcohol (\>50 ml/day)
• •25. Significant abnormalities in the electrocardiogram
• •26. Positive PCR test for COVID-19
• •27. Positive serology for HIV, hepatitis B or hepatitis C
• •28. Abnormal clinical laboratory test results (that according to the principal investigator's judgement are considered clinically significant)
• •29. Uncooperative volunteers