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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfenex, Inc
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Adverse event (AE) and serious adverse event (SAE) incidence
研究概览
简要总结
The purpose of this study is to compare the safety, tolerability, and blood levels of two interferon beta-1b products, Betaferon and PF530, in healthy volunteers.
详细描述
This is a double-blind, randomised, two-treatment cross-over study in healthy adult subjects to compare the safety, tolerability, pharmacokinetics and pharmacodynamics of PF530 and Betaferon. Half of the subjects will be randomised to receive PF530 first and Betaferon second, and the other half will be randomised to receive the drugs in reverse sequence. Each study participant will complete two 7-day study periods (Period 1 and Period 2), separated by a 14-day washout period. In Part I of the study, 12 subjects will be enrolled for an initial assessment. In Part II, up to 36 additional subjects may be enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Females of childbearing potential must agree to use two effective methods of birth control, practice complete abstinence, or confirm sterilization of monogamous male partner
- •Males must have had a documented vasectomy, practice complete abstinence or use a condom and refrain from sperm.
- •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.
- •Able to understand and sign the written Informed Consent Form
排除标准
- •Female subjects who are pregnant or lactating.
- •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.
- •Previous treatment with any interferon product, including investigational use.
- •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).
- •Positive screening test for human immunodeficiency virus (HIV).
- •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.
- •History of epilepsy, seizure disorder or any unexplained black-outs.
- •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.
- •History of severe allergic or anaphylactic reactions or a known allergy to any component of the interferon β-1b formulation.
- •History of drug or alcohol abuse less than or equal to 12 months prior to Screening.
- •History of tobacco use less than or equal to 6 months prior to Screening.
- •A positive test for drugs of abuse or alcohol during Screening or prior to dosing.
- •Unwilling or unable to abstain from alcohol from 7 days prior to dosing until end-of-study assessments.
- •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.
研究组 & 干预措施
PF530/Betaferon
Single subcutaneous injection of two interferon beta-1b products (PF530 and Betaferon) 0.25 mg
干预措施: Interferon beta-1b (PF530, Betaferon) (Drug)
Betaferon/PF530
Single subcutaneous injection of two interferon beta-1b products (Betaferon and PF530) 0.25 mg
干预措施: Interferon beta-1b (PF530, Betaferon) (Drug)
结局指标
主要结局
Adverse event (AE) and serious adverse event (SAE) incidence
时间窗: 28 Days
次要结局
- Serum area-under-the-curve (AUC) of PF530 and Betaferon(72 hours)
- Serum maximum concentration (Tmax) of PF530 and Betaferon(72 hours)
- Serum neopterin(168 hours)
- Serum half-life (t1/2) of PF530 and Betaferon(72 hours)
- Serum myxovirus resistance protein A(168 hours)