ISRCTN18150742已完成1 期
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 个研究点目标入组 80 人开始时间: 2021年3月30日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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)
排除标准
- •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
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