CTRI/2020/03/023769已完成1 期
An Open-Label, Single-Treatment, Single-Period, Single Dose, Clinical Phase 1 Study To Assess The Safety And Tolerability Of Recombinant Hepatitis E Vaccine (Adsorbed) 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
- •1)Male subjects aged between 18 and 45 years (both inclusive).
- •2)Body weight > 50 kg and BMI within the range 18.5 - 29.9 kg/m2 (Both inclusive).
- •3)Ability to communicate effectively with study personnel.
- •4)Willingness to adhere to the protocol requirements.
- •5)Be able to give consent for participation in the trial.
- •6)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
- •1)History of anaphylaxis or serious reactions to any vaccines
- •2)Subjects who are taking immunostimulant therapy (e.g. interferons) or immunosuppressant medications (e.g. corticosteroids, cytotoxic drugs or antimetabolites, etc.).
- •3)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.
- •4)Subjects who have received immunoglobulins parenterally during the preceding 3 months.
- •5)Subjects who have received any vaccine in the preceding 6 months.
- •6)History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or any other body system involvement.
- •7)History or presence of significant alcoholism or drug abuse within the past one-year.
- •8)History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco product.Blood pressure less than 100/60 (Systolic/diastolic) mm Hg or more than 140/90 (Systolic/diastolic) mm Hg.
- •9)Pulse less than 60/minute or more than 100/minute.
- •10)History of fever in last 2 weeks
- •11)Any clinically significant ECG abnormalities during screening.
- •12)Any clinically significant abnormal laboratory values during screening.
- •13)Any clinically significant chest X-Ray findings during screening.
- •14)Major illness during 3 months before the screening period.
- •15)Subjects who have participated in drug research studies within past 3 months.
- •16)Subjects who have donated one unit (350ml) of blood in the past 3 months.
研究者
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