NCT05501717进行中（未招募）1 期
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study of Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Subcutaneous ALXN2030 in Healthy Participants
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 purpose of this study is to assess the safety and tolerability of single ascending doses of ALXN2030 in healthy participants.
详细描述
Approximately 48 healthy adult participants (36 participants will be on ALXN2030 and 12 participants will be on placebo) are expected to be enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 participants
- •QTcF ≤ 450 msec at Screening and on admission (ie, on Day -1).
- •Participants of Japanese descent are defined as: First generation (born to 2 Japanese parents and 4 Japanese grandparents).
- •Participants of Japanese descent must be between 20 and 60 years of age.
- •BMI within the range 18-32kg/m2 (inclusive) at Screening.
排除标准
- •Current or recurrent disease
- •Current or relevant history of physical or psychiatric illness.
- •Any other significant disease or disorder that, in the opinion of the Investigator, may put the participant at risk.
- •Female participants who are pregnant or breastfeeding.
- •Major surgery or hospitalization within 90 days prior to dosing on Day
- •History of allergy or hypersensitivity to an oligonucleotide or GalNAc moiety or any excipients of ALXN2030.
研究组 & 干预措施
ALXN2030 Dose A
Experimental
ALXN2030 will be administered as a single dose.
干预措施: ALXN2030 (Drug)
ALXN2030 Dose B
Experimental
ALXN2030 will be administered as a single dose.
干预措施: ALXN2030 (Drug)
ALXN2030 Dose C
Experimental
ALXN2030 will be administered as a single dose.
干预措施: ALXN2030 (Drug)
ALXN2030 Dose D
Experimental
ALXN2030 will be administered as a single dose.
干预措施: ALXN2030 (Drug)
ALXN2030 Dose E
Experimental
ALXN2030 will be administered as a single dose.
干预措施: ALXN2030 (Drug)
Placebo
Placebo Comparator
Placebo will be administered as a single dose.
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 through through study completion, an average of 1 year
次要结局
- Maximum Observed Plasma Concentration (Cmax)(Days 1 (predose; end of infusion (EOI); and 0.25, 0.5, 1, 2, 4, 6, 8, and 12 hours post-EOI), 2, 3, 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, and 127)
- Time to Maximum Observed Plasma Concentration (Tmax)(Days 1 (predose; EOI; and 0.25, 0.5, 1, 2, 4, 6, 8, and 12 hours post-EOI), 2, 3, 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, and 127)
- Area Under the Plasma Concentration Versus Time Curve From Time 0 (Dosing) to the Last Quantifiable Concentration (AUCt)(Days 1 (predose; EOI; and 0.25, 0.5, 1, 2, 4, 6, 8, and 12 hours post-EOI), 2, 3, 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, and 127)
- Change from Baseline in Plasma Concentration of Complement Component 3 (C3) Protein(Baseline (Day 1) and study completion, an average of 1 year)
- Change from Baseline in Serum Complement Functional Activity(Baseline (Day 1) and Day 127)
- Number of Participants With Treatment-Emergent Antidrug Antibodies (ADAs)(Days 1 through study completion, an average of 1 year)
研究者
研究点 (1)
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