THN391-NEU-102
Research type
Research Study
Full title
A Double-Blind, Randomized, Placebo-Controlled, Phase 1b Study to Assess the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of THN391 in Early Alzheimer’s Disease Subjects.
IRAS ID
1011890
Contact name
Bradford Navia
Contact email
Sponsor organisation
Therini Bio Inc.
Eudract number
2024-519899-72
Clinicaltrials.gov Identifier
Research summary
THN391 is an antibody that was produced in the laboratory and is now in development for treatment of neurodegenerative disorders, including Alzheimer’s disease (AD). It is intended to target the protein fibrin, an important protein involved in clotting. Fibrin deposits are increased in brains of people with dementia. The primary study objectives are to assess the safety, tolerability, and pharmacokinetics (the concentration in the body over time) of multiple doses of THN391 in people with Early AD with cerebral small vessel disease (cSVD). cSVD is an indicator of deposition of fibrin in the brain. In approximately 2 sites in UK and 2 in The Netherlands, male and female subjects will be enrolled, aged 65 to 85 years with Early AD and cSVD. Subjects will be randomized to receive 3 doses of THN391 or placebo. Placebo is an inactive drug that looks just like THN391. Randomized means that subjects will be randomly assigned to receive THN391 or placebo. Neither the subject nor the staff will know who is getting THN391 and who is getting placebo. However, if the subject experiences any important side effects, the doctor can find out whether the subject is getting THN391 or placebo. Study drug will be administered over an approximately 60-minute infusion, once every 4 weeks. Subjects will remain in the clinical unit for at least 24 hours following the first administration of study drug. They will return to the clinic for the second and third doses and for multiple evaluations up to the End of Study (Day 248). Subjects will undergo clinical and laboratory-based safety-related assessments, as well as blood collections at different time points. Assessments will include brain MRIs, spinal taps, electrocardiograms, vital signs, physical and neurological examinations, blood draws, adverse event recordings, monitoring of mental health, and tests to determine the severity of AD. Informed consent will be obtained from all subjects before any study-related procedures are conducted.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
25/LO/0205
Date of REC Opinion
2 May 2025
REC opinion
Further Information Favourable Opinion