NCT07352423招募中1 期
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of ALXN2230 in Healthy Adult Participants
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
研究概览
简要总结
The primary objective of this study is to evaluate the safety and tolerability of single subcutaneous (SC) doses of ALXN2230 in healthy participants.
详细描述
Part A of this study is expected to enroll approximately 40 participants (30 on ALXN2230 and 10 on placebo) across 5 cohorts and Part B is expected to enroll approximately 8 participants (6 on ALXN2230 and 2 on placebo) in 1 cohort.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- •Baseline immunoglobulin G (IgG) concentrations ≥ 1000 milligrams per deciliter (mg/dL) and ≤ 1600 mg/dL at Screening.
- •Antibody titers for Tetanus toxoid (≥ 0.1 International Units per milliliter (IU/mL)) at Screening.
- •Nonsmokers and not using any nicotine-containing products. A nonsmoker is defined as an individual who has abstained from smoking for at least 1 year prior to Screening.
- •BMI within the range 18 to 32 kilograms per square meter (kg/m2), inclusive; with body weight ≥ 50 kilograms (kg).
排除标准
- •History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
- •Abnormal blood pressure (BP) (resting BP not to exceed 140/80 mmHg and no less than 90/60 mmHg).
- •Participants who have history of allergy or hypersensitivity to excipients in ALXN
- •History of unexplained, recurrent infection, or infection requiring treatment with systemic antibiotics within 90 days prior to dosing on Day
- •Pregnant or breastfeeding females are excluded from the clinical study.
- •Participants with known clinically relevant immunological disorders.
- •Lymphoma, leukemia, breast cancer 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 5 years.
- •ALT > 1.0 × upper limit of normal (ULN)
- •TBIL > 1.0 × ULN
- •Current or chronic history of liver disease or known hepatic or biliary abnormalities (with exception for Gilbert's syndrome).
- •QTc > 450 millisecond (msec) for male participants or > 470 msec for female participants.
- •Significant blood loss (including blood donation [> 500 mL]) or had a transfusion of any blood product within 12 weeks prior to dosing or plan 1 within 4 weeks after the end of the study.
- •Additional inclusion/exclusion criteria may apply, per protocol.
研究组 & 干预措施
ALXN2230
Experimental
Participants will be enrolled across multiple cohorts and will receive a single dose of ALXN2230.
干预措施: ALXN2230 (Drug)
Placebo
Placebo Comparator
Participants will be enrolled across multiple cohorts and will receive a single dose of placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
时间窗: Day 1 up to Day 113
次要结局
- Maximum Observed Serum Concentration (Cmax) of ALXN2230(Day 1 up to Day 113)
- Time to Cmax (Tmax) of ALXN2230(Day 1 up to Day 113)
- Area Under the Concentration-time Curve from Time 0 to the Last Quantifiable Concentration (AUCt) of ALXN2230(Day 1 up to Day 113)
- Serum Concentration of Biomarkers(Day 1 up to Day 113)
研究者
研究点 (1)
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