NCT07745907招募中1 期
A Phase 1, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of AMG 691 Administered in Healthy Chinese and Japanese Participants
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Amgen
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Maximum Observed Serum Concentration (Cmax) of AMG 691
研究概览
简要总结
The trial is designed to evaluate the pharmacokinetics, safety, tolerability, and immunogenicity of AMG 691 in healthy Chinese and Japanese participants
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female participants, 18 to 60 years of age.
- •First-generation Chinese ancestry (born in China, Hong Kong, Taiwan, or Macau with 2 Chinese parents and 4 Chinese grandparents) or first-generation Japanese ancestry (born in Japan with 2 Japanese parents and 4 Japanese grandparents).
- •Body mass index (BMI) 18.0 to 30.0 kg/m^2 (inclusive) and body weight ≥40 kg.
- •In good general health based on medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory evaluations.
- •Female participants must not be pregnant or breastfeeding.
- •Participants of reproductive potential must agree to follow protocol-specified contraception requirements.
- •Willing to maintain usual diet and physical activity regimen throughout study participation.
排除标准
- •Clinically significant medical condition, disease, or abnormal finding that could interfere with study participation or interpretation of results.
- •Clinically significant ECG abnormalities
- •Clinically significant abnormal blood pressure or pulse rate at screening/check-in.
- •History of malignancy (except adequately treated in situ cervical cancer or non-melanoma skin cancer >5 years before dosing).
- •Deep vein thrombosis or pulmonary embolism within 3 months prior to check-in.
- •History of hypersensitivity/anaphylaxis to biologic therapies, mammalian-derived products, or AMG 691 excipients.
- •Active, chronic, recurrent, or unresolved infection; history of severe infection requiring intravenous (IV) antibiotics within the past 3 years.
- •Positive or indeterminate QuantiFERON-TB Gold test.
- •Untreated or unresolved helminth parasitic infection.
- •History of immunodeficiency.
- •Receipt of live or live-attenuated vaccines within 12 weeks before check-in or planned during the study.
- •Estimated glomerular filtration rate (eGFR) <70 mL/min/1.73 m^
- •Alanine Aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, or direct bilirubin >1.5 × Upper Limit Normal (ULN).
- •Positive screening tests for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection.
- •Use of prohibited prescription, over-the-counter, herbal, vitamin, or dietary supplement products within 30 days (or 5 half-lives) before enrollment, unless approved by the investigator.
- •History of illicit drug use within 1 year, positive drug screen, or unwillingness to abstain from illicit drugs/cannabinoids during the study.
- •Use of tobacco or nicotine-containing products within 6 months prior to check-in.
- •History of alcohol abuse or excessive alcohol consumption.
- •History of non-suicidal self-injury within 5 years or unstable major depressive disorder/other severe psychiatric disorder within 2 years.
- •Participation in another investigational drug study within 90 days (or 5 half-lives) prior to check-in.
- •Previous exposure to AMG
- •Recent donation of blood, plasma, or platelets.
- •Any participant considered unsuitable by the investigator or unwilling to comply with study restrictions.
结局指标
主要结局
Maximum Observed Serum Concentration (Cmax) of AMG 691
时间窗: Day 1 up to Day 154
Area Under the Serum Concentration Time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUC0-t) of AMG 691
时间窗: Up to Day 154
Area Under the Serum concentration Time Curve from Time Zero to Infinity (AUC0-inf) of AMG 691
时间窗: Up to Day 154
次要结局
- Number of Participants with Serious Adverse Events (SAEs)(From screening (Day -28) up to end of trial (approximately 154 days))
- Number of Participants Who Develop Anti-AMG 691 Antibodies(Up to Day 154)
- Number of Participants with Treatment-emergent Adverse Events (TEAEs)(Day 1 to end of trial (approximately 154 days))
研究者
研究点 (1)
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