ACTRN12623000786695进行中（未招募）1 期
A Phase 1, Randomized, Blinded, Placebo-Controlled, Single and Multiple Dose, First-in-human Study of the Safety, Tolerability, and Pharmacokinetics of APG777 in Healthy Participants
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Healthy men and women, as determined by physical examination, laboratory screening tests, and medical history
- •Body mass index (BMI) of 18 to 35 kg/m2 (inclusive), weight less than 120 kg
- •Willing to use a highly effective method of contraception from admission through 12 months or 5 half-lives, whichever is longer, after the last administration of study drug
排除标准
- •Evidence of clinically significant abnormalities or disease, including, but not limited to,
- •a) Hemoglobin A1c more than or equal to 6.5% and/or diagnosis of diabetes mellitus;
- •b) Positive test for human immunodeficiency virus (HIV) antibody;
- •c) Acute or chronic hepatitis B or C;
- •d) Diagnosis or suspected diagnosis of immunodeficiency or autoimmune diseases, or undergoing immunosuppressive therapy; d)Significant history or clinical manifestation of any metabolic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, acute or chronic infectious diseases and malignancies, as determined by the Investigator
- •History of severe allergic reactions or hypersensitivity (ie, anaphylaxis)
- •Known or suspected intolerance or hypersensitivity to any biologic medication or known allergies or clinically significant reactions to murine, chimeric, or human proteins, mAbs or antibody fragments, or to any components of the formulation of APG777 and its excipients used in this study
- •If female, nursing, lactating, pregnant. or plans to become pregnant within 12 months or 5 half-lives (whichever is longer) of last study drug administration
- •Use of any prescription or non-prescription medication 48 hours prior to dosing (exception: contraceptives or acetaminophen/paracetamol up to 2 g per day prior to dosing is permitted).
- •Vaccination within 14 days prior to administration of APG777
- •Use of any investigational drug therapy within 30 days or 5 half-lives (whichever is longer) prior to study drug dosing through 5 half-lives after the last dose of study drug
研究者
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