JPRN-jRCT2071200057已完成1 期
A Phase I, Randomized, Single-Blind, Multicenter, Parallel-Group, Single-Dose Study to Compare Pharmacokinetic Characteristics and Safety of FKB327 with those of Humira in Healthy Adult Male Subjects - FKB327-006 Study
Yazawa Rie0 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
The primary PK similarity analysis showed that, in the primary PK parameters (Cmax and AUC0-t) and secondary PK parameters (AUC0-infinity, AUC0-360h, and t1/2), the 90% CIs of the geometric LS mean ratios were fully contained within the pre-defined PK similarity range of 0.80 to 1.25. There was no difference in safety profile and immunogenicity between the treatment groups. The study demonstrated PK similarity and confirmed comparable safety profiles between FKB327 and Humira.
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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