Phase 1, Open-label, Randomized, Parallel Study to Assess the Pharmacokinetic Comparability of 2 Formulations and to Evaluate Pharmacokinetic Comparability of Guselkumab (CNTO1959) Delivered by 2 Different Devices in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 141
- 主要终点
- Maximum observed serum concentration (Cmax) of guselkumab
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetic (what the body does to the medication) comparability of guselkumab in lyophilized and liquid formulations. Also to evaluate pharmacokinetic comparability of liquid formulation of guselkumab when delivered as prefilled syringe with UltraSafe Passive Delivery System [PFS-U] or with a prefilled syringe facilitated injection device [PFS FID]) following a single subcutaneous (SC) administration of 100 mg guselkumab in healthy participants.
详细描述
This is an open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), parallel study (each group of participants will be treated at the same time) of guselkumab in healthy participants. Approximately 140 participants will be randomly assigned in the ratio 2:2:2:1 in to 4 treatment groups: Group 1 (SC injection of lyophilized formulation), Group 2 (subcutaneous [SC] injection of liquid formulation with PFS-U), Group 3 (SC injection of liquid formulation with PFS-FID), and Group 4 (IV infusion of liquid formulation). The study consists of 3 phases: screening (up to 4 weeks), open-label treatment and inpatient follow up (1 week) and outpatient follow up (11 weeks). Safety evaluations will include assessment of adverse events, vital signs, physical examination, electrocardiograms, injection-site reactions, and clinical laboratory tests. The total duration of the study for each participant will be approximately 16 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy participant with no clinically significant abnormalities
- •Have a weight in the range of 60 kg to 90 kg for male participants; have a weight in the range of 50 kg to 80 kg for female participants
- •Have a body mass index (BMI) of 18.5 kg/m2 to 29.0 kg/m2
- •Agrees to protocol-defined use of effective contraception
排除标准
- •Participant has a history of any clinically significant medical illness including liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances, ophthalmological disorders, neoplastic disease, urinary tract diseases, or dermatological disease
- •Currently have any known malignancy or have a history of malignancy
- •Participant has a known or suspected intolerance or hypersensitivity to any biologic medication or known allergies or clinically significant reactions to murine, chimeric, or human proteins to monoclonal antibodies or antibody fragments
- •Have had a Bacillus Calmette-Guérin (BCG) vaccination within 12 months of screening
研究组 & 干预措施
Group 1
40 participants will receive a single subcutaneous (SC) injection of 100 mg guselkumab prepared from lyophilized formulation.
干预措施: Guselkumab (lyophilized formulation) (Drug)
Group 2
40 participants will receive a single SC injection of 100 mg guselkumab, liquid formulation with UltraSafe Passive Delivery System (PFS-U).
干预措施: Guselkumab (liquid formulation with PFS-U) (Drug)
Group 3
40 participants will receive a single SC injection of 100 mg guselkumab, liquid formulation with a prefilled syringe facilitated injection device (PFS FID).
干预措施: Guselkumab (liquid formulation with PFS FID) (Drug)
Group 4
20 participants will receive a single intravenous (IV) infusion of 100 mg guselkumab prepared from liquid formulation.
干预措施: Guselkumab (liquid formulation) (Drug)
结局指标
主要结局
Maximum observed serum concentration (Cmax) of guselkumab
时间窗: Day 1 through Week 12
Area under the curve (AUC) from time 0 to 70 days of guselkumab
时间窗: Day 1 through Week 12
次要结局
- Number of participants with adverse events as a measure of safety and tolerability(Up to 12 weeks)
- Absolute bioavailability of guselkumab(Day 1 through Week 12)
- Immunogenicity of guselkumab(Day 1 through Week 12)