NCT06214481已完成1 期
A Phase 1, Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Rocatinlimab (AMG 451) Administered Subcutaneously in Healthy Chinese 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
- 发起方
- Amgen
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) of Rocatinlimab
研究概览
简要总结
The primary objective of the study is to evaluate the pharmacokinetics of rocatinlimab after single subcutaneous (SC) administration in healthy Chinese participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be a resident in mainland China, and of Chinese ancestry (participants whose parents within 3 generations are of Chinese ancestry).
- •Healthy male or female participants, between 18 and 65 years of age (inclusive) at the time of screening.
- •Body mass index between 18 and 30 kg/m^2 (inclusive) at the time of screening and check-in.
- •Provide signed informed consent.
排除标准
- •History or evidence, at screening or check-in, of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the investigator (or designee), would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
- •Evidence of any active bacterial, viral, or fungal infection at screening including but not limited to upper or lower respiratory tract infection, conjunctivitis, acute otitis media, gastritis, enteritis, skin infections, infections requiring treatment with systemic therapy (antibiotics, antiviral, antiparasitic, antiprotozoal, or antifungals) for which therapy has not been completed within 4 weeks before enrollment.
- •Immunocompromised participants at risk for viral reactivation including participants with history of solid organ transplantation, hematopoietic stem cell transplantation, or cellular therapy.
- •Participants with disrupted skin integrity (apparent burn or dermatitis).
- •Prior history of autoimmune disease including but not limited to inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), lupus, rheumatoid arthritis, psoriasis/psoriatic arthritis, multiple sclerosis.
- •Positive hepatitis B surface antigen (HBsAg)/hepatitis B core antibody (HBcAb) or hepatitis C virus antibody and/or positive human immunodeficiency virus test, at screening. Participants whose hepatitis B and C results are compatible with prior immunity (resulting from inoculation) may be included.
- •Positive T-spot test at screening.
- •Participants who have received live vaccines within 5 weeks prior to screening, or plan to receive live vaccines within 120 days after administration of an investigational product.
- •Participants who have received coronavirus disease 2019 vaccine within 30 days prior to check-in, or plan to receive a coronavirus disease 2019 vaccine within 120 days post-dose.
- •Use of any over-the-counter or prescription medications within 30 days or 5 half-lives (whichever is longer) before check-in.
- •Acetaminophen (paracetamol; up to 2 g/day) for analgesia will be allowed.
- •Hormone replacement therapy (e.g., estrogen) and hormonal contraceptives will be allowed.
- •Participant has received a dose of an investigational drug within the past 90 days or 5 half-lives, whichever is longer, prior to check-in.
- •Have previously completed or withdrawn from this study or any other study investigating rocatinlimab or have previously received the investigational product.
研究组 & 干预措施
Rocatinlimab
Experimental
Participants will receive a single SC dose of rocatinlimab.
干预措施: Rocatinlimab (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of Rocatinlimab
时间窗: Up to day 126
Area Under the Serum Concentration Time Curve (AUC) from Time Zero to the Time of the Last Measurable Concentration (AUClast) of Rocatinlimab
时间窗: Up to day 126
AUC from Time Zero to Infinity (AUCinf) of Rocatinlimab
时间窗: Up to day 126
次要结局
- Number of Participants Experiencing Serious Adverse Events(Up to day 126)
- Number of Participants who Develop Anti-rocatinlimab Antibodies(Up to day 126)
- Number of Participants Experiencing Treatment-emergent Adverse Events(Up to day 126)
研究者
研究点 (1)
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