CTRI/2018/08/015145
尚未招募
1 期
Phase-I, Blinded, Randomized, Parallel-group, Single dose, Comparative Pharmacokinetic Study of DRL_Adalimumab (DRL_AU) and Reference Adalimumab Administered by the Subcutaneous Route to Normal Healthy Male Subjects.
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Dr Reddys Laboratories Ltd
- 状态
- 尚未招募
- 最后更新
- 4年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\.Healthy male subjects, 18 to 50 years of age
- •2\.BMI between 18\.5 \- 30\.0 kg/m2 and body weight of 50 â?? 80 kg
- •3\.Have all screening results within acceptable range
- •4\.Non\-smoker, non\-alcoholic and should not be consuming tobacco
- •5\.Capable, and amenable to providing written informed consent to the study requirements.
排除标准
- •1\.Positive result for T.B., syphilis, hepatitis B \& C, or HIV
- •2\.Live virus vaccination within 3 months prior to screening
- •3\.Any prior exposure to adalimumab or to any other TNF
- •4\.History of immunodeficiency or other clinically significant immunological disorders, or auto\-immune disorders.
- •5\.Any history of hypersensitivity or allergic reactions.
- •6\.QTc (Friedericia correction) longer than 450 milliseconds.
- •7\.Any nervous system disease and systemic disease considered as significant
- •8\.Any active infection or non\-healed wound ongoing at the time of screening or dosing.
- •9\.Any disorder that may interfere with the safety of the subject, the study evaluations or the subject compliance to the study procedures and limitations.
- •10\.History of any cancer, including carcinoma in situ, lymphoma or leukemia.
结局指标
主要结局
未指定
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