IBC-01-01
Research type
Research Study
Full title
A First in Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of IBCAb002 in Persons with Early Alzheimer's Disease
IRAS ID
1004442
Contact name
Stella Marincheva
Contact email
Sponsor organisation
ImmunoBrain Checkpoint, Inc.
Eudract number
2021-006580-19
Clinicaltrials.gov Identifier
Research summary
Alzheimer's disease (AD) is the most common type of neurodegenerative dementia. The clinical features of AD include progressive impairment of behavioral and cognitive functions such as memory, comprehension, language, attention, reasoning, and judgment. In the US alone, approximately 5.8 million Americans over the age of 65 have AD, and this number is expected to increase to 7.1 million by 2025. In Europe, the prevalence of AD was estimated at 5.05%.
IBC-Ab002 represents a novel therapeutic approach for AD. IBC-Ab002 targets the immune system, the exhaustion or deficiency of which are common factors in aging, disease emergence and progression. The aim of IBC-Ab002 administration is to break age/disease related adaptive immune suppression by blocking the Programmed cell death protein 1 (PD-1)/ Programmed death-ligand 1 (PD-L1) inhibitory immune checkpoint pathway. The clinical trial is funded by ImmunoBrain Checkpoint Ltd. and it is planned to include approximately 8 centers in United Kingdom, Netherlands and Israel and will enroll at least 40 and up to approximately 60 subjects aged 50-75 years with early Alzheimer's Disease (AD). The objectives of the study are to gain a preliminary understanding of the safety, tolerability, and pharmacokinetics of IBC-Ab002 in the study population. In addition, the study will explore the effects of IBC-Ab002 on pharmacodynamic markers of peripheral immune system activity, biomarkers of AD-related pathology and clinical and electrophysiological measures of brain function. The study will have an adaptive design and will be carried out in two parts. Part A will be comprised of a Single-Ascending-Dose study and Part B will continue dosing of Part A subjects as a Multiple-Ascending Dose study. Subjects in five sequential cohorts of 8 subjects each will be assigned in a 3:1 ratio to receive either IBC-Ab002 or matching placebo. The expected duration for each participating patient will be up to 54 weeks in total including the Screening.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
22/YH/0082
Date of REC Opinion
27 May 2022
REC opinion
Further Information Favourable Opinion