A first-in-human, randomized, placebo-controlled, double-blind, sequential single and multiple ascending dose (SAD/MAD) study with open-label food effect and pharmacodynamic assessment arms to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ACI-3024

AC Immune (Switzerland)0 sites80 target enrollmentMarch 30, 2021

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: AC Immune (Switzerland)
Enrollment: 80
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 30, 2021

End Date

August 24, 2020

Last Updated

5 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

AC Immune (Switzerland)

Eligibility 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

•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