NCT04816513已完成1 期
An Open-label, Randomized, Parallel-group Study to Assess the Bioequivalence of Ustekinumab Following a Single Subcutaneous Administration by Two Different Injection Devices 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
- 300
- 试验地点
- 2
- 主要终点
- Maximum Observed Serum Concentrations (Cmax) of Ustekinumab
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetic (PK) and bioequivalence (BE) of ustekinumab administered by a single subcutaneous (SC) injection with Device 1 or Device 2 in healthy participants.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be a non-user or a 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
- •Body weight within the range of 50.0 kilograms (kg) to 90.0 kg, inclusive and body mass index within the range of 18 kilograms per meter square (kg/m^2) to 30 kg/m^2 (inclusive)
- •A female participant must have a negative pregnancy test result at screening and baseline (Day -1) and while enrolled in this study
- •A woman must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for a period of 12 weeks after study intervention
- •A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum 12 weeks after receiving the last dose 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, neurologic 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 previously received ustekinumab
- •Received an investigational intervention (including investigational vaccines or devices) or used an invasive investigational device within 30 days or 5 half lives before screening or is currently enrolled in an investigational study
- •Has a current chronic infection, prior history of recurrent infection, or an active infection
研究组 & 干预措施
Ustekinumab (Using Reference Device)
Active Comparator
Participants will receive a single subcutaneous (SC) injection of ustekinumab in Device 1 as a reference device on Day 1.
干预措施: Ustekinumab (Drug)
Ustekinumab (Using Test Device)
Experimental
Participants will receive a single SC injection of ustekinumab in Device 2 as a test device on Day 1.
干预措施: Ustekinumab (Drug)
结局指标
主要结局
Maximum Observed Serum Concentrations (Cmax) of Ustekinumab
时间窗: Up to Day 85
Cmax is maximum observed serum concentration of ustekinumab.
Area Under the Serum Concentration Versus Time Curve from Time Zero to Infinity (AUC [0-Infinite])
时间窗: Up to Day 85
AUC (0-Infinite) defined as area under the serum concentration versus time curve from time zero to infinity with extrapolation of the terminal phase will be evaluated.
次要结局
- Number of Participants with Treatment-emergent Adverse Events (TEAEs)(Up to Day 85)
- Number of Participants with Abnormalities in Laboratory Tests(Up to Day 85)
- Number of Participants with AEs Related to the Injection or at the Injection Site(Up to Day 85)
- Number of Participants with Abnormalities in Vital Signs(Up to Day 85)
- Number of Participants with Abnormalities in Physical Examinations (PE)(Up to Day 85 (for full PE) and up to Day 57 (for brief PE))
- Number of Participants with Antibodies to Ustekinumab(Up to Day 85)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
A Pharmacokinetic Study of Ustekinumab in Pediatric Subjects With Moderately to Severely Active Crohn's DiseaseCrohn DiseaseNCT02968108Janssen Research & Development, LLC45
已完成
2 期
A Study of Ustekinumab (STELARA®) in Adult Japanese Participants With Severe Atopic DermatitisDermatitis, AtopicNCT01945086Janssen Pharmaceutical K.K.79
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
3 期
An Efficacy and Safety Study of Ustekinumab (CNTO 1275) in Participants With Plaque PsoriasisPsoriasisNCT00723528Janssen Pharmaceutical K.K.158
已完成
1 期
Bioequivalence Study of Levetiracetam Tablet and Intravenous Infusion in Healthy Japanese SubjectsHealthy VolunteersNCT01394224UCB Pharma25