A Phase 1, Single and Multiple Ascending Dose and Food Effect Study of NEU-411 Administered Orally to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 147
- 试验地点
- 1
- 主要终点
- Evaluate the safety and tolerability of single dosing, food effect and multiple oral doses of NEU-411 in healthy subjects
研究概览
简要总结
This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose (SAD), food effect (FE),multiple ascending dose (MAD), drug-drug interaction study, and bioavailability - bio-equivalence study of orally administered NEU-411 in healthy subjects
详细描述
Up to five (5) single-ascending oral doses will be administered to 40 healthy adult male or female subjects (aged 18-80 years, inclusive). Escalation to the next higher dose level may occur only after evaluation of the safety and PK results of the previous dose level (at least 6 evaluable subjects). Within each cohort, 6 subjects will receive one dose of NEU-411, and 2 subjects will receive one dose of matching placebo. Dose levels may be revised based on available safety and PK data.
Food effect will evaluate approximately 8 subjects in a fasted versus fed state.
Multiple ascending oral doses will be administered up to 24 healthy subjects (aged 18 - 80 years, inclusive) in 3 sequential dosing groups (8 subjects in each dosing group). Six (6) subjects will receive NEU-411 and two (2) subjects will receive matching placebo in each dosing group (cohort) for 7 days. Escalation to the next higher dose level may occur only after evaluation of the safety and PK results of the previous dose level (at least 6 evaluable subjects). Dose levels may be revised based on available safety and PD data.
Multiple oral dosing will be administered in up to 39 healthy subjects in 3 sequential dosing groups (13 subjects across 3 dosing groups) over 28 days.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects for standard cohorts must be 18-80 years, inclusive, at the time of signing the informed consent;
- •Subjects who are in good general health with no clinically relevant abnormalities based on the medical history, physical examinations, neurological examinations, clinical laboratory evaluations (hematology and clinical chemistry)
- •Subjects who have a body mass index (BMI) of 18-32 kg/m2(inclusive);
- •Male subjects are eligible to participate if they are rendered surgically sterile (at least 6 months), or agree to the following during the study and for at least 30 days after the last dose of study drug:
- •Refrain from donating sperm;
- •AND, either:
- •Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; OR Agree to use a male condom (contraception/barrier) and should also be advised of the benefit for a female partner to use an acceptable, highly effective method of contraception as a condom may break or leak when having sexual intercourse;
- •Female subjects are eligible to participate if they are not pregnant or breastfeeding, subject to one of the following:
- •Women of childbearing potential (WOCBP), defined as women physiologically capable of becoming pregnant, must have a negative serum pregnancy test at the Screening visit and a negative urine pregnancy test on Day -1; WOCBP must agree to use an acceptable, highly effective contraceptive method from Screening until 30 days after the last dose of study treatment (see Section 11.3); OR
- •Menopausal women must have an elevated serum follicle-stimulating hormone level (FSH) level at Screening; if the FSH is not elevated, they are considered to be of childbearing potential (unless permanently sterile) and must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1
排除标准
- •History of clinically significant hematological, renal, pancreatic, gastrointestinal, hepatic, cardiovascular, metabolic, endocrine, immunological, allergic disease, or other major disorders
- •History of clinically significant abnormal chest x-ray
- •Clinically significant neurologic disorder
- •Contraindications to undergo a lumbar puncture (only for subjects participating in the MAD)
研究组 & 干预措施
NEU-411
Part A: Single-ascending dose cohorts; food effect; Part B: Multiple-ascending dose cohorts (7 days)
干预措施: NEU-411 (Drug)
Placebo
Part A: Single-ascending dose cohorts; food effect; Part B: Multiple-ascending dose cohorts (7 days)
干预措施: Placebo (Drug)
结局指标
主要结局
Evaluate the safety and tolerability of single dosing, food effect and multiple oral doses of NEU-411 in healthy subjects
时间窗: Up to 7 days of dosing
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
次要结局
- PK parameter(Up to 7 days of dosing)