NCT04617691已完成1 期
An Open-label, Randomized, Parallel-group Study to Assess the Bioequivalence of the Intravenous Formulation of Guselkumab Using Prefilled Syringes Assembled in an UltraSafe Plus Passive Needle Guard and Intravenous Formulation of Guselkumab Using Final Vialed Product in Healthy Participants
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Maximum Observed Serum Concentration (Cmax)
研究概览
简要总结
The purpose of this study is to evaluate the bioequivalence of an intravenous (IV) administration of the guselkumab formulation using UltraSafe Plus Passive Needle Guard (PFS-U) to create the IV solution versus the guselkumab formulation using Final Vialed Product (FVP) (IV) to create the IV solution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be healthy on the basis of physical examination, medical history, vital signs and electrocardiogram (ECG) performed at screening. Any abnormalities must be considered not clinically significant and this determination must be recorded in the participant's source documents and initialed by the investigator
- •Be healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
- •A female participant must have a negative pregnancy test result at screening and baseline (Day -1) and while enrolled in this study
- •Must be a non-user or light user of tobacco products (not smoke more than 10 cigarettes or equivalent a day for at least 6 months prior to screening), including all nicotine use, example, cigarettes (including e-cigarettes or the equivalent of e-cigarettes), cigars, chewing tobacco, patch, gum
- •Participant is considered eligible according to the following tuberculosis (TB) screening criteria: (a) have no history of latent or active TB before screening; (b) have no signs or symptoms suggestive of active TB upon medical history and/or physical examination; (c) have had no recent close contact with a person with active TB; (d) have a negative QuantiFERON-TB test result within 28 days prior to the administration of study intervention
排除标准
- •History of any clinically significant medical illness or medical disorders the investigator considers should exclude the participant, including (but not limited to), neuromuscular, hematological disease, immune deficiency state, respiratory disease, hepatic or gastrointestinal disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease
- •History of malignancy before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
- •Has a current chronic infection, prior history of recurrent infection, or an active infection
- •Received any systemic immunosuppressant agent (other than a short course of corticosteroids for minor inflammatory conditions) within 6 months before and during screening and administration of study intervention
- •Has a positive urine drug or alcohol screen during screening or at admission (Day -1)
研究组 & 干预措施
Group 1: Guselkumab PFS-U
Experimental
Participants will receive single intravenous (IV) guselkumab formulation using UltraSafe Plus Passive Needle Guards (PFS-U) to create the IV solution.
干预措施: Guselkumab (Drug)
Group 2: Guselkumab FVP
Experimental
Participants will receive single IV guselkumab formulation using Final Vialed Product (FVP) to create the IV solution.
干预措施: Guselkumab (Drug)
结局指标
主要结局
Maximum Observed Serum Concentration (Cmax)
时间窗: Up to Day 85
Cmax is defined as maximum observed serum concentration.
Area Under The Serum Concentration Versus Time Curve From Time 0 to Infinity Based on Extrapolation of The Terminal Phase (AUC[0-infinity])
时间窗: Up to Day 85
AUC(0-infinity) is defined as area under the serum concentration vs time curve from time 0 to infinity based on extrapolation of the terminal phase.
次要结局
- Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)(Up to Day 85)
- Percentage of Participants with Serious Adverse Events (SAEs)(Up to Day 85)
- Percentage of Participants with Clinically Significant Changes in Physical Examinations(Up to Day 85)
- Percentage of Participants with Antibodies to Guselkumab(Up to Day 85)
- Percentage of Participants with Clinically Significant Changes in Vital Signs(Up to Day 85)
- Percentage of Participants with Clinically Significant Changes in Laboratory Safety Tests(Up to Day 85)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
GXR RM China BE Study (Darmstadt - Jiangsu)HealthyNCT05463094Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany84
已完成
1 期
A Study to Evaluate Zilucoplan Injected Subcutaneously Either by a Prefilled Syringe or an Auto-injector in Healthy Adult ParticipantsHealthy VolunteersNCT06511076UCB Biopharma SRL14
已完成
1 期
Pharmacokinetics (PK) and Pharmacodynamics (PD) of Mayne Glucagon for Injection Compared With Glucagen® (Novo Nordisk) in Healthy VolunteersHypoglycemiaNCT00745186Hospira, now a wholly owned subsidiary of Pfizer28
已完成
1 期
A Study to Assess Bioequivalence of a New Tapentadol Extended-Release Tablet With Respect to a Tapentadol Extended Release Tablet Under Fasted Conditions in Healthy SubjectsHealthyNCT02019485Johnson & Johnson Pharmaceutical Research & Development, L.L.C.64
已完成
1 期
A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components in Healthy Fed ParticipantsHealthyNCT02071368Janssen Research & Development, LLC3