NL-OMON31518已完成不适用
*A Two Part Phase I Study to Assess Safety, Tolerability, Systemic Exposure and Effect on Analgesia and Anaesthesia of Single and Multiple doses of TDT 077 in Healthy Older Subjects.* - Single and multiple rising dose study.
Celtic Pharma Development Services Europe Ltd.0 个研究点目标入组 96 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
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
- 年龄范围
- 18 至 99（—）
入选标准
- •Subjects must voluntarily sign a written informed consent agreement;
- •Age 55-75 years except cohort 6B. Age 18-40 for cohort 6B;
- •Female subjects should be of non-childbearing potential (surgically sterile or more than 1 year post-menopausal) or if of childbearing potential must be using a medically acceptable form of birth control for the duration of the study;
- •Male subjects: you are not able to cause a pregnancy or uses a medically acceptable form of birth control for th duration of the study;
- •Subjects must be in good health;
- •Body Mass Index (BMI) between 18 and 30 (inclusive), with body weight greater than or equal to 60 kg and less than or equal to 100 kg;
- •No clinically significant abnormalities at screening
排除标准
- •Subjects with a known hypersensitivity or allergy to bupivacaine, other local anaesthetics or to any of the excipients in TDT 077 (Part 1A and Part 2);
- •Subjects with a known hypersensitivity or allergy to lidocaine and/or prilocain, other local anaesthetics or to any of the excipients in EMLA® hydrophilic cream (Part 1B);
- •Subject has any skin irritation or disease that might interfere with absorption of study drug or skin irritation assessment, including eczema, psoriasis, melanoma;
- •Subjects with active presence or history of alcoholism or drug addiction;
- •Subject has a tattoo or other skin deformities that might interfere with skin irritation assessment;
- •Subject has had a surgery within the last 3 months prior to dosing;
- •Female subjects that are pregnant or lactating;
- •Subjects who have used prescription medication within two weeks prior to the first dosing day, except for contraceptives or HRT;
- •Subjects who have used over-the-counter medication (including homeopathic medicines and vitamins), within 96 hours prior to the dosing day;
- •Subjects who have been treated with other local anaesthetic therapy within 3 weeks prior to dosing;
- •Subjects who smoke more than 10 cigarettes per day and who are unable to abstain from smoking when at the study centre;
- •Subjects who participated in an investigational drug study within 3 months prior to the dosing day;
- •Subjects who have lost or donated >350 ml of blood within 12 weeks prior to the screening session;
- •Subjects who test positive for HBsAg, Anti-HCV or HIV;
- •Subjects with a relevant food or drug hypersensitivity or allergy;
- •Subjects who are considered unsuitable to participate in the study for any reason in the opinion of the principal investigator.
研究者
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