CTRI/2015/06/005908已完成1 期
An Open -Label, Single-treatment , single period, single dose, clinical phase 1 study to asess the safety and tolerability of hepatitis B vaccine(r-DNA)I. P of M/s Cadila Healthcare Ltd, India in healthy , adult, male, human subjects.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
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
入选标准
- •Male subjects aged between 18 and 45 years (both inclusive).
- •Subjectsâ?? weight within +/-15% of the ideal height-weight chart of Life Insurance Corporation of India for non-medical cases.
- •Ability to communicate effectively with study personnel.
- •Willingness to adhere to the protocol requirements.
- •Be able to give consent for participation in the trial.
- •Normal health as determined by personal medical history, clinical examination, and laboratory examinations data during screening (within the clinically acceptable range).
排除标准
- •History of anaphylaxis or serious reactions after previous dose of any hepatitis B containing vaccines or to any other component of the vaccine, including yeast.
- •Subjects who are taking immunostimulant therapy (e.g. interferons) or immunosuppressant medications (e.g. corticosteroids, cytotoxic drugs or antimetabolites, etc.).
- •Subjects who are known to be suffering from diseases which can affect immune competence e.g. diabetes, immunodeficiency disorders or known to be HIV positive.
- •Subjects who have received immunoglobulins parenterally during the preceding 3 months.
- •Subjects who have received any vaccine in the preceding 6 months.
- •History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or any other body system involvement.
- •History or presence of significant alcoholism or drug abuse within the past one-year.
- •History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco product.
- •Difficulty with donating blood.
- •Blood pressure less than 100/60 (Systolic/diastolic) mm Hg or more than 140/90 (Systolic/diastolic) mm Hg.
- •Pulse less than 60/minute or more than 110/minute.
- •Any ECG abnormalities.
- •Any clinically significant abnormal laboratory values during screening.
- •Any clinically significant chest X-Ray findings during screening.
- •Major illness during 3 months before the screening period.
- •Subjects who have participated in drug research studies within past 3 months.
- •Subjects who have donated one unit (350ml) of blood in the past 3 months.
研究者
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