Multiple System Atrophy, Parkinson’s Disease (PD)
Conditions
Brief summary
To determine the occurrence of AEs and SAEs after 4 treatment cycles by assessing the frequency, severity, causality, and nature of AEs and SAEs; also changes in ECG, vital signs (arterial blood pressure, heart rate, and temperature), and laboratory tests (hematology, serum chemistry, and urine) will be assessed for tolerability. The severity of the AEs and SAEs will be determined by CTCAE v5.0.
Detailed description
The recommended maximal dose will be defined by the safety and tolerability profile and PK data., Exposure levels of exidavnemab in serum (i.e., PK parameters of exidavnemab)., Immunogenicity; determination of ADAs in serum by using a tier-based approach followed by determination of NAbs if relevant.
Interventions
DRUGnothing (blank / empty saline solution)
DRUGExidavnemab
Sponsors
BioArctic AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the occurrence of AEs and SAEs after 4 treatment cycles by assessing the frequency, severity, causality, and nature of AEs and SAEs; also changes in ECG, vital signs (arterial blood pressure, heart rate, and temperature), and laboratory tests (hematology, serum chemistry, and urine) will be assessed for tolerability. The severity of the AEs and SAEs will be determined by CTCAE v5.0. | — |
Secondary
| Measure | Time frame |
|---|---|
| The recommended maximal dose will be defined by the safety and tolerability profile and PK data., Exposure levels of exidavnemab in serum (i.e., PK parameters of exidavnemab)., Immunogenicity; determination of ADAs in serum by using a tier-based approach followed by determination of NAbs if relevant. | — |
Countries
Poland, Spain
Outcome results
None listed