A study to assess the safety and tolerability of ACI-3024 and how the drug affects and interacts with the body

Phase 1

Completed

• Conditions: Alzheimer Disease; Nervous System Diseases; Alzheimer disease

• Registration Number: ISRCTN18150742
• Lead Sponsor: AC Immune (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-08-24
• Study Start: 2021-03-30
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified