Resumen

Pharmacokinetic/Pharmacodynamic Study of 2 agalsidase beta Formulations in Single Dose Administered to Healthy Volunteers as intravenous infusion, at a concentration of 1 mg/kg

Descripción detallada

Volunteers will receive either one or the other agalsidase beta formulation. Drug will be administered as an intravenous 5h infusion. Plasma samples will be taken at different time points, from before infusion up to 12h later. Pharmacokinetic (PK) and pharmacodynamic (PD) profile will be determined, and bioequivalence evaluated.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 40 YearsSexo: MALE

Criterios de inclusión

Male subjects between the ages of 18 and 40
Body mass index (BMI) between 19 and 25 kg/m².
Volunteers whose complementary exams (ECG, chest X-ray, blood and urine, PCR for COVID-19), performed prior to their inclusion are within the normal range and/or are not clinically significant according to the investigator's judgement.
Subjects with systolic blood pressure higher than 110 mmHg and lower than 139 mmHg, diastolic blood pressure higher than 70 mmHg and lower than 89 mmHg with a heart rate higher than 50 and lower than 90 beats per minute after being seated for 5 minutes and, then, standing up (extreme values are included)
Volunteers who are well disposed to the study and have signed the approved informed consent prior to the start of the study

Criterios de exclusión

History of clinically significant allergies (except for untreated asymptomatic seasonal allergies)
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
Volunteers who are receiving other drugs (prescription or over-the-counter) or who have within the 2 weeks prior to the study
Volunteers with history of autoimmune diseases.
Chronic disorders of the CNS, psychological and/or psychiatric disorders: bipolar disorder, severe depression, insomnia, changes in personality
Active or chronic infections
Having received live or inactivated viral or bacterial vaccines, within the fifteen days prior to visits 1 or 2
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.
Known allergies to any of the components of the formulations
Active smoker, of more than 10 cigarettes/day
Current clinical evidence of severe digestive disorders, surgeries of the gastrointestinal tract (except for appendectomy)
Current clinical evidence of kidney disease
Current clinical evidence of liver disorders
Current clinical evidence of respiratory and cardiac disease
Presence of diabetes mellitus, thyroid dysfunction or other endocrine disorders
Evidence of active gastroduodenal disease
History of peripheral thrombotic phenomena
Underlying neurological disease
Presence of a current progressive chronic disease
History of drug or alcohol abuse or addiction within the last three years
Participation in a clinical study within the last three months
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.
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.
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)
Significant abnormalities in the electrocardiogram
Positive PCR test for COVID-19
Positive serology for HIV, hepatitis B or hepatitis C
Abnormal clinical laboratory test results (that according to the principal investigator's judgement are considered clinically significant)
Uncooperative volunteers

Intervenciones

biological

Agalsidase beta from Biosidus 1 mg/kg

Patients received an infusion of 1 mg/kg of Agalsidase Beta from Biosidus. Final infusion dose is achieved with lyophilized drug at concentration 35 mg and 5 mg

biological

Fabrazyme (agalsidase beta) 1 mg/kg

Patients received an infusion of 1 mg/kg of Fabrazyme. Final infusion dose is achieved with lyophilized drug at concentration 35 mg and 5 mg

Comparative Pharmacokinetic and Pharmacodynamic Study Between 2 Agalsidase Beta Formulations at a Single Dose of 1 mg/kg of Agalsidase (Biosidus) and Fabrazyme (Sanofi Genzyme) as Intravenous Infusion in Male Healthy Volunteers