Agalsidase beta from Biosidus 1 mg/kg ( DrugBank: Agalsidase beta )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
19ライソゾーム病1

19. ライソゾーム病


臨床試験数 : 899 薬物数 : 684 - (DrugBank : 99) / 標的遺伝子数 : 51 - 標的パスウェイ数 : 182
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05343715
(ClinicalTrials.gov)
October 23, 202124/1/2022PK/PD Study of 2 Agalsidase Formulations in Single Dose of 1 mg/kg Administered to Healthy Volunteers as IV InfusionComparative 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 VolunteersFabry DiseaseBiological: Agalsidase beta from Biosidus 1 mg/kg;Biological: Fabrazyme (agalsidase beta) 1 mg/kgBio Sidus SANULLActive, not recruiting18 Years40 YearsMale20Phase 1Argentina