JPRN-jRCT2071200058已完成1 期
A Phase I, Randomized, Single-Blind, Single-Dose Study to Compare Pharmacokinetic Characteristics and Safety of FKB327 with those of Humira in Healthy Adult Male Subjects - FKB327-004 Study
Yonemura Takuma0 个研究点目标入组 130 人开始时间: 2020年11月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 130
研究概览
简要总结
In the primary PK similarity analysis, the 90% CIs of the geometric LS mean ratios for Cmax and AUC0-360h were fully contained within the predefined PK similarity range of 0.80 to 1.25, although the upper limit of 90% CI of the geometric LS mean ratio for AUC0-t was slightly outside the pre-defined range. In the planned supplementary analysis including the ADA categorical titers as a covariate, all primary PK endopoint met equivalent range.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 45age old（—）
- 性别
- Male
入选标准
- •Japanese healthy male subjects
- •aged 20 to 44 years, with body mass index (BMI) of >= 18.5 and < 25.0 kg/m2.
排除标准
- •1. History or presence of illness (including drug or alcohol dependence, drug allergy, allergic disease (including severe natural rubber-latex allergy), respiratory disease, endocrine, renal, or hepatic disease, diabetes mellitus, or cardiac disease)
- •2. A history of cancer.
- •3. History or presence of psychiatric disease.
- •4. Evidence of any significant bacterial, viral, fungal, or parasitic infection within 28 days before dosing.
- •5. Positive for any one of infectious disease testing (Hepatitis B surface (HBs), anti-HBc antibody, Hepatitis C virus (HCV), Human immunodeficiency virus (HIV) antigen-antibody), and tuberculosis.
- •6. Positive for any one of drugs of abuse test.
- •7. History of hepatitis B.
- •8. Participated in another clinical study or any other type of medical research within 4 months before dosing.
- •9. Previous treatment with adalimumab.
- •10. Receipt of a live vaccine (e.g., BCG, polio, measles, rubella) within the 3 months before dosing.
- •11. History of ADAs to any drug.
研究者
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