NCT06994936已完成1 期
An Open-label, Randomized, Parallel-group, Single-dose Relative Bioequivalence Study of Sonelokimab Administered Subcutaneously Either by a Prefilled Syringe or an Autoinjector in Healthy Adults
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
- 120
- 试验地点
- 1
- 主要终点
- Comparison of pharmacokinetics (PK) of an AI versus PFS administered single dose of sonelokimab
研究概览
简要总结
This is a study to confirm the relative bioequivalence of sonelokimab administered subcutaneously via a prefilled syringe (PFS) or an autoinjector (AI) in healthy adult volunteers
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be between 18 and 55 years of age with suitable veins for cannulation or repeated venipuncture .
- •Participants must have a body weight greater than 40 kg and body mass index (BMI) between 21 and 30 kg/m2, inclusive.
- •Participants who are overtly healthy as determined by medical evaluation including medical history, physician examination, laboratory tests, and cardiac monitoring.
- •Female participants are eligible to participate if they are not pregnant or breastfeeding
- •Male participants must be willing to use a condom when sexually active with a partner of childbearing potential during the study, unless surgically sterile.
排除标准
- •History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
- •History of clinically significant infections.
- •Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric.
- •History of hypersensitivity, intolerance, or severe adverse reaction to any drug compound, any history of anaphylaxis or angioedema, or any history of severe food allergy/intolerance requiring systemic treatment.
- •Participants with transaminase and liver function test results outside of the normal reference range, following a confirmatory test, if appropriate
- •Participants with other clinically significant laboratory test results that are likely to introduce additional risk factors or interfere with the study procedures or interpretation.
研究组 & 干预措施
Sonelokimab via an AI
Experimental
干预措施: Sonelokimab (Drug)
Sonelokimab via a PFS
Experimental
干预措施: Sonelokimab (Drug)
结局指标
主要结局
Comparison of pharmacokinetics (PK) of an AI versus PFS administered single dose of sonelokimab
时间窗: 64 days
To compare the PK of an AI versus PFS administered single-dose of sonelokimab in terms of area under the time concentration curve from time zero to timepoint with last measurable concentration (AUC0-t)
次要结局
- Assessment of safety and tolerability(64 days)
- Evaluation of the impact of injection site location on PK(64 days)
- Immunogenicity of sonelokimab(64 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy ParticipantsHealthy VolunteersNCT05533801Eisai Inc.160
已完成
1 期
Phase 1/2 Study of TAK-850 Subcutaneous Injection in Healthy AdultsInfluenza InfectionNCT02313155Takeda110
已完成
1 期
A Study of Intravenous Formulation of Guselkumab Using Prefilled Syringes and Final Vialed Product in Healthy ParticipantsHealthyNCT04617691Janssen Research & Development, LLC140
已完成
3 期
A Study to Compare Subcutaneous Versus Intravenous Administration of RoActemra/Actemra (Tocilizumab) in Participants With Moderate to Severe Active Rheumatoid ArthritisRheumatoid ArthritisNCT01194414Hoffmann-La Roche1,262
已完成
1 期
A Study of JNJ-73763989 in Adult Participants With Renal ImpairmentRenal ImpairmentNCT04963738Janssen Research & Development, LLC29