NCT04379869已完成1 期
A Combined Single Dose and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of NNZ-2591 in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Safety and Tolerability measured through Adverse Events /Serious Adverse Events
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of NNZ-2591 when administered to healthy volunteers.
详细描述
This study is in two stages:
Stage 1: A First-in-Human (FIH), single dose escalation study of oral NNZ-2591 in healthy volunteers to establish safety, tolerability and pharmacokinetic parameters.
Stage 2: A First-in-Human (FIH), randomised, double-blind, placebo-controlled, Multiple Ascending Dose study (MAD) in healthy volunteers to establish safety, tolerability and pharmacokinetic parameters.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Stage 1: None Stage 2: Double-blind
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects aged 18 to 55 years, inclusive;
- •Weight at screening and admission between 45 kg and 100 kg;
- •Body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive;
- •Healthy as determined by the Investigator based on pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead electrocardiogram (ECG);
- •Negative tests for Hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV) and human immunodeficiency virus (HIV)-1 and HIV-2 antibody at screening;
- •Clinical laboratory test results up to >1.5 x Lower Limit of Normal (LLN) or <1.5 x Upper Limit of Normal (ULN) at screening and admission and deemed not clinically significant by the Investigator;
- •Negative screen for alcohol and drugs of abuse at screening and admission;
- •Non-smokers or ex-smokers (must have ceased smoking >3 months prior to screening visit);
- •Woman with no childbearing potential by reason of surgery or at least 1year post- menopause (i.e., 12 months post last menstrual period), and menopause confirmed by follicle-stimulating hormone (FSH) testing;
- •If of childbearing potential, using an effective nonhormonal method of contraception (intrauterine device; condom or occlusive cap [diaphragm or cervical or vault caps]; true abstinence; or vasectomized male partner (provided that he is the sole partner of that subject and had a vasectomy ≥30 days prior to screening) for the duration of the study and up to one month after the last investigational medicinal product (IMP) administration;
- •Negative serum pregnancy test at screening and negative urine pregnancy test on admission (women of childbearing potential only);
- •Using an effective method of contraception (condom) if sexually active with a female partner of child-bearing potential; true abstinence; or vasectomy ≥30 days prior to screening) throughout the study and for one month after the last IMP administration.
排除标准
- •Subjects who have a clinically relevant history as determined by the Investigator, or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders;
- •Fridericia's correction factor for QT (QTcF) > 450 ms for male participants and >470ms for female participants or history of QT interval prolongation.
- •Have a clinically relevant surgical history, as determined by the Investigator;
- •Have a history of relevant atopy or drug hypersensitivity;
- •Have a history of alcoholism or drug abuse;
- •Consume more than 21 standard drinks a week for males and more than 14 standard drink if female [1 standard drink is any drink containing 10g of alcohol, regardless of container size or alcohol type].
- •Have a significant infection or known inflammatory process on screening or admission;
- •Have acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea, heartburn) at the time of screening or admission;
- •Have used any prescription or non-prescription medicines within 2 weeks of admission, unless in the investigator's opinion will not affect determination of safety or other study assessments. Occasional paracetamol use (up to 2g/day is permitted);
- •Have received any investigational drug within 30 days prior to screening;
- •Have used tobacco or nicotine products within 3 months of screening
- •Have donated or received any blood or blood products within the 3 months prior to screening;
- •Cannot communicate reliably with the investigator;
- •Are unlikely to co-operate with the requirements of the study;
- •Are unwilling or unable to give written informed consent.
- •Pregnancy or breast-feeding;
- •Woman of childbearing potential not willing to use an accepted effective contraceptive method or using hormonal contraceptives;
- •Not willing to use an accepted effective method of contraception.
研究组 & 干预措施
NNZ-2591 MAD Cohort 2
Experimental
Multiple Ascending Dose (MAD) of oral NNZ-2591 in healthy volunteers
干预措施: NNZ-2591 (Drug)
NNZ-2591 Single dose Cohort 1
Experimental
Single dose of oral NNZ-2591 in healthy volunteers
干预措施: NNZ-2591 (Drug)
NNZ-2591 Single dose Cohort 2
Experimental
Single dose of oral NNZ-2591 in healthy volunteers
干预措施: NNZ-2591 (Drug)
NNZ-2591 MAD Cohort 1
Experimental
Multiple Ascending Dose (MAD) of oral NNZ-2591 in healthy volunteers
干预措施: NNZ-2591 (Drug)
NNZ-2591 MAD Cohort 1
Experimental
Multiple Ascending Dose (MAD) of oral NNZ-2591 in healthy volunteers
干预措施: Placebo (Drug)
NNZ-2591 MAD Cohort 2
Experimental
Multiple Ascending Dose (MAD) of oral NNZ-2591 in healthy volunteers
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and Tolerability measured through Adverse Events /Serious Adverse Events
时间窗: 25 days
The frequency and severity of Adverse Events in healthy volunteers administered single and repeated oral doses of NNZ-2591
次要结局
- Pharmacokinetic - t1/2(17 days)
- Pharmacokinetic - AUC∞(17 days)
- Pharmacokinetic - Cmax(17 days)
- Pharmacokinetic - Tmax(17 days)
研究者
研究点 (2)
Loading locations...
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