A Phase 1, Randomized, Open-label, Single-Dose, Crossover Study to Investigate the Effect of Injection Site on Relative Bioavailability of KAI-9531 Subcutaneous Injection in Participants With a Range of Body Mass Indices
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Maximum Observed Concentration (Cmax) of KAI-9531
研究概览
简要总结
The main objective of the study is to assess the relative bioavailability of KAI-9531 subcutaneous (SC) injection in the upper arm and thigh compared to the abdomen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- •Body mass index (BMI) ≥ 25.0 and ≤ 40.0 kilograms per square meter (kg/m^2), with a body weight ≤ 120 kg.
- •Medically healthy.
排除标准
- •Known hypersensitivity to the study drug or any of the study drug ingredients.
- •History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric, or neurological disease/disorder.
- •Any history of malignant disease in the last 10 years (excludes surgically resected skin squamous cell or basal cell carcinoma).
- •Estimated glomerular filtration rate (eGFR) <60 milliliters per minute per 1.73 square meters of body surface area (mL/min/1.73 m^2) using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
- •Glycosylated hemoglobin (HbA1c) test result ≥6.5%.
- •A history of or positive test results at the Screening visit for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody (HCVab) with HCV ribonucleic acid (RNA) confirmation if positive.
- •Positive drugs of abuse or alcohol test results.
- •Participation in another clinical study of an investigational drug or investigational device within 30 days or 5 half-lives of the investigational drug (whichever is longer).
- •Any other condition or prior therapy that would make the participant unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.
- •Note: Additional inclusion/exclusion criteria may apply, per protocol.
研究组 & 干预措施
KAI-9531: Abdomen Injection Site
Participants will receive KAI-9531 as a SC injection into the abdomen on Day 1 of either Treatment Period 1, 2 or 3.
干预措施: KAI-9531 (Drug)
KAI-9531: Thigh Injection Site
Participants will receive KAI-9531 as a SC injection into the thigh on Day 1 of either Treatment Period 1, 2 or 3.
干预措施: KAI-9531 (Drug)
KAI-9531: Upper Arm Injection Site
Participants will receive KAI-9531 as a SC injection into the upper arm on Day 1 of either Treatment Period 1, 2 or 3.
干预措施: KAI-9531 (Drug)
结局指标
主要结局
Maximum Observed Concentration (Cmax) of KAI-9531
时间窗: Treatment Period 1, 2 and 3: Pre-dose and up to 672 hours post-dose
Area Under the Concentration-time Curve From 0 to Time of Last Quantifiable Concentration (AUC0-t) of KAI-9531
时间窗: Treatment Period 1, 2 and 3: Pre-dose and up to 672 hours post-dose
Area Under the Concentration-time Curve From 0 to Infinity (AUC0-inf) of KAI-9531
时间窗: Treatment Period 1, 2 and 3: Pre-dose and up to 672 hours post-dose
次要结局
- Number of Participants Who Experience Antidrug Antibodies to KAI-9531(Day 1 to Day 113)
- Number of Participants Who Experience a Serious Adverse Event (SAE)(Day 1 to Day 113)
- Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)(Day 1 to Day 113)