Alzheimer Disease Nervous System Diseases Alzheimer disease
Conditions
Interventions
Participants will be randomly allocated to one of the 4 arms of the study:
1. Single ascending doses oral intake with ACI-3024
2. Single dose oral intake with placebo
Sponsors
AC Immune (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 20 to 59 years inclusive (non-elderly participants), or 60 to 80 years inclusive (elderly participants) Non-Japanese participants: 1. Body mass index between 18.0 and 30.0 kg/m² 2. Body weight between 50 and 100 kg (males) or between 45 and 80 kg (females) Japanese participants: 1. First-generation Japanese subjects (biological parents and all biological grandparents are of exclusively Japanese descent and were born in Japan) 2. Body mass index between 17.0 and 30.0 kg/m² 3. Body weight between 45 and 100 kg (males) or between 40 and 80 kg (females)
Exclusion criteria
Exclusion criteria: 1. History of, or current: liver or renal insufficiency; clinically significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, psychiatric or metabolic disturbances; any inflammatory illness; or any other illness that the investigator considers should exclude the subject and which may interfere with the study assessments 2. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator MAD cohorts only: 1. Lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months according to the Columbia Suicide Severity Rating Scale (C-SSRS) at screening 2. Screening brain MRI scan that shows evidence of significant abnormality that would suggest a clinically significant finding that may impact the subject’s ability to safely participate in the study, in the opinion of the investigator 3. History of alcoholism or drug/chemical abuse within 2 years prior to screening. 4. Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) at screening or check in 5. History of human immunodeficiency virus (HIV) antibody positive or tests positive for HIV at screening 6. History of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-hepatitis C virus) positive, or positive hepatitis panel at screening 7. Positive pregnancy test result at screening or check in 8. Clinically significant impaired hepatic function at screening or check in , defined as either of the following (confirmed by repeat): 8.1. Serum ALT or AST >1.25 × upper limit of normal 8.2. Total bilirubin >1.5 × upper limit of normal 9. Serum albumin or total plasma protein outside of the clinical reference range for the testing laboratory at screening or check in 10. Creatinine clearance <60 ml/min as assessed by the Cockcroft-Gault equation Participants undergoing MRI (MAD part): 1. Have any contraindications for MRI studies, including claustrophobia, or the presence of metal (ferromagnetic) implants, or a cardiac pacemaker
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety/tolerability measured using Adverse events (AEs), physical and neurological examinations, vital signs measurements, 12 lead electrocardiogram parameters, incidence of laboratory abnormalities, and MRI in multiple ascending dose cohorts over 37 days (SAD part) or 70 Days (MAD part) | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK) measured using levels of ACI-3024 in plasma, urine, and cerebrospinal fluid (CSF) by liquid chromatography over 7 days (SAD part) or 28 Days (MAD part) | — |
Countries
United Kingdom
Contacts
Public ContactHliva Valérie
Outcome results
None listed