NCT06677138已完成1 期
A Phase 1 Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Gefurulimab (ALXN1720) in Healthy Chinese Adults
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
- 8
- 试验地点
- 1
- 主要终点
- Maximum Observed Serum Concentration (Cmax) of Gefurulimab
研究概览
简要总结
The primary objective of this study is to characterize the PK properties of a single dose of gefurulimab 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be 18 to 45 years of age, inclusive, at the time of signing the informed consent.
- •Body weight within ≥ 45 kg to < 110 kg and BMI within the range 18 to 30 kg/m2 (inclusive) at Screening and Admission (Day -1).
- •Participants who are healthy as determined by medical evaluation with no clinically significant or relevant abnormalities as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluation.
- •QTcF ≤ 450 msec for male participants and ≤ 460 msec for female participants at Screening and prior to dosing on Day
- •Documented vaccination against N meningitidis serotypes A, C, W-135, Y at least 28 days and not more than 3 years prior to dosing on Day 1.
排除标准
- •History of any Neisseria meningitidis infection.
- •History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders.
- •Abnormal blood pressure as determined by the Investigator.
- •History of latent or active TB (Tuberculosis) or exposure to endemic areas.
- •Active systemic bacterial, viral, or fungal infection within 14 days prior to dosing.
- •History of latent or active TB or exposure to endemic areas within 8 weeks prior to the Screening Visit confirmed by QuantiFERON®-TB test.
- •Significant allergies to humanized biologics.
- •Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions.
- •History of clinically significant allergic reaction (eg, anaphylaxis or angioedema) to any product (eg, food, pharmaceutical).
- •History of allergy or intolerance to penicillin or cephalosporin.
- •Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
- •Current or chronic history of liver disease.
- •Evidence of human immunodeficiency virus (HIV) infection (positive HIV type 1 or type 2 antibody).
- •Evidence of hepatitis B infection (positive hepatitis B surface antigen [HBsAg] or positive total hepatitis B core antibody [HBcAb] with negative surface antibody [anti-HBs]), or hepatitis C viral infection (positive HCV RNA).
- •Female participants who have a positive pregnancy test at Screening or Admission.
- •Positive prestudy drug/alcohol screen; positive result may be repeated once.
研究组 & 干预措施
gefurulimab
Experimental
Participants will receive a single SC dose of gefurulimab in the abdomen on Day 1.
干预措施: gefurulimab (Drug)
结局指标
主要结局
Maximum Observed Serum Concentration (Cmax) of Gefurulimab
时间窗: Day 1 predose through Day 92 postdose
Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Gefurulimab
时间窗: Day 1 predose through Day 92 postdose
次要结局
- Serum Free Complement Component 5 (C5) Concentration(Day 1 predose through Day 92 postdose)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)(Day 1 through Day 92)
- Number of Participants With Anti-drug Antibodies (ADAs)(Day 1 through Day 92)
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Associated With Prefilled Syringe With Needle Safety Device (PFS-SD)(Day 1 through Day 92)
- Number of Participants With Successful and Failed Dose Administrations(Day 1 through Day 92)
研究者
研究点 (1)
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