ACTRN12622001449729已完成1 期
A Randomized, Double-blind, Placebo-controlled Phase I Study to assess the safety and tolerability of Subcutaneous EQ102 Administered in a Single and Multiple Ascending Dose Schedule.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •1. Males and females 18 to 55 years of age inclusive.
- •2. Body mass index (BMI) 18.0 to 32.0 kg/m2, with a body weight greater than or equal to 50 kg.
- •3. Medically healthy without clinically significant abnormalities.
- •4. Have suitable venous access for blood sampling
- •5. Additional vaccine requirements as outlined in the 'Public notes' field below
排除标准
- •1. History of chronic alcohol abuse or excessive alcohol intake within 12 weeks prior to screening.
- •2. History of substance abuse or drug addiction within 12 months prior to first study drug administration and positive drug test results.
- •3. History of relevant drug hypersensitivity.
- •4. Smoke more than 2 nicotine containing products or equivalent per week or who are not willing to abstain from smoking 7 days prior to admission and during the confinement period(s).
- •5. Use of systemic immunomodulatory or immunosuppressant treatments 1 month or 5 half-lives of the medication (whichever is longer) prior to screening. Topical or inhaled corticosteroids are acceptable.
- •6. Use of any prescription or over-the-counter medication (including herbal products) – exceptions include oral contraceptives, occasional use of ibuprofen, paracetamol, topical ointments, and vitamins or dietary supplements.
- •7. Receipt of any investigational drug within 1 month of screening.
- •8. Positive for HIV-1 or HIV-2, hepatitis B virus (HBV), or Hepatitis C virus (HCV)
- •9. Positive QuantiFERON TB Test.
- •10. Use of any live or live attenuated vaccinations within 30 days prior to the first study drug administration except for vaccines for influenza.
- •11. Donation or receipt of blood or blood products.
- •12. Regular, excessive consumption of caffeine-containing products.
研究者
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