NCT07214766已完成1 期
A Phase 1, Randomized, Two-Part, Parallel-Group Study to Assess the Bioequivalence of Subcutaneously Administered Trastuzumab Via Different Subcutaneous Delivery Platforms in Healthy Male Subjects
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
- 331
- 试验地点
- 7
- 主要终点
- Part 1: Area Under the Concentration-Time Curve from Hour 0 to 21 days Postdose (AUC0-21days) of Trastuzumab
研究概览
简要总结
This two-part study will evaluate the bioequivalence, safety, and tolerability of a single SC dose of trastuzumab administered via handheld syringe/syringe pump (HHS/SP) with infusion set (IS) and an on-body delivery system (OBDS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Within body mass index (BMI) range 18 to 38 kilogram per meter square (kg/m2), inclusive. Body weight <=100 kg
- •Left ventricular ejection fraction (LVEF) >= 55 percent (%) measured by echocardiogram (ECHO)
- •Negative test result for drugs of abuse
- •Negative test result for hepatitis B surface antigen, hepatitis C virus (HCV), or human immunodeficiency virus (HIV) antibody screen
- •Negative test for latent Tuberculosis (TB) infection by QuantiFERON® TB Gold
- •Agree to use contraception and will refrain from sperm donation
排除标准
- •Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, respiratory, gastrointestinal, immunological, neurological, or psychiatric disorder; acute infection; or other unstable medical disease
- •History of moderate or severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins
- •Known sensitivity to recombinant hyaluronidase or other form of hyaluronidase
- •History or presence of atrial fibrillation
- •History of any clinically significant or clinically relevant cardiac condition
- •History or presence of clinically significant electrocardiogram (ECG) abnormalities
- •History of uncontrolled hypertension, hyperlipidemia, thyroid disorder, or diabetes
- •Family history of clinically significant and clinically relevant hypersensitivity, allergy, or severe cardiac diseases
- •History of previous anti-cancer treatments including pertuzumab, trastuzumab, anthracyclines, or any cardiotoxic drugs
- •History of active or latent TB, regardless of treatment history
- •Poor peripheral venous access
- •History or presence of any malignancy, with the exception of completely excised basal cell or squamous cell carcinoma of the skin
研究组 & 干预措施
Part 1
Experimental
Participants will receive formulation 1 of trastuzumab SC via OBDS or HHS/SP with IS.
干预措施: Trastuzumab (Drug)
Part 2
Experimental
Participants will receive formulation 2 of trastuzumab SC via OBDS or HHS/SP with IS.
干预措施: Trastuzumab (Drug)
结局指标
主要结局
Part 1: Area Under the Concentration-Time Curve from Hour 0 to 21 days Postdose (AUC0-21days) of Trastuzumab
时间窗: Up to Day 57
Part 1: Maximum Observed Concentration (Cmax) of Trastuzumab
时间窗: Up to Day 57
Part 2: AUC0-21days of Trastuzumab
时间窗: Up to Day 57
Part 2: Cmax of Trastuzumab
时间窗: Up to Day 57
次要结局
- Percentage of Participants with Adverse Events (AEs)(Up to Day 57)
研究者
研究点 (7)
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