A Phase 1 Study of NEU-627 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Evaluate the safety and tolerability of single and multiple doses of NEU-627 in healthy participants
研究概览
简要总结
Phase 1, randomized, double-blind, placebo-controlled study of NEU-627 designed to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect.
详细描述
This is a Phase 1 study that will utilize a randomized, double-blind placebo controlled single ascending dose schema, a 10-day multiple ascending dose schema, and open-label schemas to study food effect and to determine cerebrospinal fluid concentration of NEU-627. The study will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect of NEU-627 in male and female healthy volunteers between 18 to 60 years old, inclusive.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants are eligible to be included in the study only if all of the following criteria apply.
- •Male and female participants must be 18-60 years, inclusive, at the time of signing the informed consent;
- •Participants must be in good general health according to the judgment of the Investigator per local guidance;
- •Participants who have a body mass index (BMI) of 18-32 kg/m2 (inclusive);
- •When engaging in sex with a woman of child-bearing potential, both the male participant and his female partner must use highly effective contraception;
- •Legally and ethically capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
排除标准
- •Participants are excluded from the study if any of the following criteria apply.
- •Clinically significant infection and/or dermatological, cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, gastrointestinal, immunological, neurological, or psychiatric disease which could interfere with, or the treatment for which might interfere with, the conduct of the study or which would, in the opinion of the Investigator, unacceptably increase the participant's risk if he/she were to participate in the study;
- •Any history of malignant disease in the last 5 years;
- •Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions;
- •Use of or plans to use systemic immunosuppressive or immunomodulating medications during the study or within 3 months prior to the first study drug administration;
- •Current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medications;
- •Positive screen for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus antibody/antigen;
- •History of active, latent, or inadequately treated tuberculosis infection.
- •Additional details and criteria are outlined in the full study protocol.
研究组 & 干预措施
NEU-627
Part A: Single-ascending dose cohorts; Part B: Multiple-ascending dose cohort; Part C: Open-label, food effect evaluation; and Part D: Open-label, determination of cerebrospinal concentration
干预措施: NEU-627 (Drug)
Placebo
Part A: Single-ascending dose cohorts; Part B: Multiple-ascending dose cohort
干预措施: Placebo (Other)
结局指标
主要结局
Evaluate the safety and tolerability of single and multiple doses of NEU-627 in healthy participants
时间窗: Up to 10 days of dosing
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
次要结局
- Evaluation of maximum concentration (Cmax) after single and multiple doses of NEU-627(Up to 10 days of dosing)
- NEU-627 concentrations(Up to 10 days of dosing)
- Change from baseline of the corrected QT interval(Up to 10 days of dosing)