ACTRN12615000218594终止1 期
A Phase 1 Double-Blind, Randomised, Two-Treatment Cross-over Study Comparing the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PF530 and Betaferon Administered by Subcutaneous Injection in Healthy Adult Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Pfenex Inc
- 入组人数
- 12
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 50 Years（—）
- 性别
- All
入选标准
- •1. Healthy male or female aged 18-50 years
- •3. Females of childbearing potential must agree to use two effective methods of birth control, practice complete abstinence, or confirm sterilization of monogamous male partner
- •5. Males must have had a documented vasectomy, practice complete abstinence or use a condom and refrain from sperm.
- •6. Body Mass Index (BMI) greater than or equal to 18.0 and less than or equal to 30.0 kg/metres squared at Screening.
- •7. Participant is free from clinically significant illness or disease as determined by medical and surgical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory assessments conducted at Screening and Day -1.
- •8. Able to understand and sign the written Informed Consent Form
- •9. Willing to follow the protocol requirements and comply with protocol restrictions.
排除标准
- •1. Female subjects who are pregnant or lactating.
- •2. History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, metabolic, psychological, musculoskeletal disease or malignancies unless deemed not clinically significant by the Principal Investigator.
- •3. History of clinically significant serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicaemia) less than or equal to 90 days prior to first dose.
- •4. History of recurring oral herpes virus (cold sores) or presence of oral herpes during Screening or at dosing.
- •5. History of chronic fatigue syndrome or fibromyalgia.
- •6. Fever (defined as body temperature greater than or equal to 38.0 degrees Celsius) or symptomatic viral or bacterial infection (including upper respiratory tract infection) less than or equal to 30 days prior to dosing.
- •7. Previous treatment with any interferon product, including investigational use.
- •8. Participants with a history of malignant disease, including solid tumours and hematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured).
- •9. A calculated creatinine clearance of less than or equal to 70 mL/min according to the Cockcroft-Gault equation.
- •10. Positive screening test for human immunodeficiency virus (HIV).
- •11. Positive screening test for hepatitis C antibody (HCV Ab) or current hepatitis B infection (defined as positive for hepatitis surface antigen [HBsAg] at Screening). Participants with immunity to hepatitis B (defined as negative HBsAg and positive hepatitis B surface antibody [HBsAb]) are eligible to participate in the study.
- •12. History of epilepsy, seizure disorder or any unexplained black-outs.
- •13. History of suicidal ideation or an episode of clinically severe depression (as determined by the Investigator).
- •14. Score of greater than or equal to 8 on either the anxiety or depression sub-scales of the Hospital Anxiety and Depression Scale (HADS) at Screening or Day -1
- •15. Score of greater than or equal to 9 on the Modified Scale for Suicidal Ideation (MSSI) at Screening or Day -1
- •16. History of hypersensitivity or intolerance to paracetamol or non-steroidal anti-inflammatory drugs (NSAID) that would preclude the use of at least 1 of these during the study.
- •17. History of severe allergic or anaphylactic reactions or a known allergy to any component of the interferon beta-1b formulation.
- •18. History of drug or alcohol abuse less than or equal to 12 months prior to Screening.
- •19. History of tobacco use less than or equal to 6 months prior to Screening.
- •20. A positive test for drugs of abuse or alcohol during Screening or prior to dosing.
- •21. Unwilling or unable to abstain from alcohol from 7 days prior to dosing until end-of-study assessments.
- •22. Use of any prescription medication, over-the-counter medication, or herbal supplements/products during Screening or throughout study, unless approved by both the Principal Investigator and the Sponsor.
- •23. Clinically significant abnormal clinical laboratory test values, as determined by the Investigator, or any value of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) that is above the upper limit of normal, any value of platelets or haemoglobin that is below the lower limit of normal, or any out-of-range value for total white blood cells,
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