ProjectMERA – A Phase 1, Blinded, Randomized, Placebo-controlled Study to Investigatethe Safety, Tolerability, and…
Basic data
Acronym:
MERA
Title:
A Phase 1, Blinded, Randomized, Placebo-controlled Study to Investigatethe Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of BIIB132Administered Intrathecally to Adults With Spinocerebellar Ataxia 3
Duration:
07/09/2022 to 31/12/2024
Abstract / short description:
Primary Objective
To evaluate the safety and tolerability of multiple ascending doses of BIIB132 administered via IT injection to participants with SCA3.
Incidence of AEs assessed from Day 1 to final study visit and SAEs assessed from Screening to final study visit.
Secondary Objective
To characterize the multiple-dose
PK of BIIB132 administered via IT
injection to participants with SCA3.
To evaluate the safety and tolerability of multiple ascending doses of BIIB132 administered via IT injection to participants with SCA3.
Incidence of AEs assessed from Day 1 to final study visit and SAEs assessed from Screening to final study visit.
Secondary Objective
To characterize the multiple-dose
PK of BIIB132 administered via IT
injection to participants with SCA3.
Keywords:
Antisense Oligonucleotid Treatment
Spinocerebellar Ataxia
Neurodegenerative Diseases
First in Human Study
Involved staff
Managers
Faculty of Medicine
University of Tübingen
University of Tübingen
University Department of Neurology
Hospitals and clinical institutes, Faculty of Medicine
Hospitals and clinical institutes, Faculty of Medicine
Local organizational units
Department of Neurology with Focus on Neurodegenerative Disorders
University Department of Neurology
Hospitals and clinical institutes, Faculty of Medicine
Hospitals and clinical institutes, Faculty of Medicine
Funders
Ismaning, Bayern, Germany