NCT05256810终止1 期
A Phase 1/2, Randomized, Double-blind, Placebo-controlled, Single Ascending and Multiple Dose Study of the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of ALN-XDH in Healthy Adult Subjects and Adult Patients With Gout
Alnylam Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2022年2月25日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Parts B and C: Frequency of Adverse Events
研究概览
简要总结
The purpose of this study is to:
- Part A: Evaluate the safety and tolerability of single ascending doses of ALN-XDH in healthy adult participants
- Part B: Evaluate the safety, tolerability and efficacy of ALN-XDH as monotherapy in adult patients with gout
- Part C: Evaluate the safety, tolerability and efficacy of ALN-XDH as add-on therapy in adult patients with gout
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Part A: has serum uric acid (sUA) level ≥4 mg/dL and ≤7 mg/dL
- •Parts B and C: meets the American College of Rheumatology criteria for acute arthritis of primary gout
- •Part B: has an sUA level ≥8 mg/dL while not receiving urate-lowering therapy (ULT) or following a 1-week washout period of prior ULT
- •Part C: has been on a stable dose of allopurinol for gout for ≥6 weeks prior to screening
- •Part C: has an sUA level ≥6 mg/dL
排除标准
- •Parts A, B and C: Has received an investigational agent within the last 30 days
- •Parts A, B and C: Has experienced or is being treated for acute gout flare(s) within 14 days prior to randomization
研究组 & 干预措施
Part A: ALN-XDH
Experimental
A single dose of ALN-XDH administered by subcutaneous (SC) injection.
干预措施: ALN-XDH (Drug)
Part A: Placebo
Placebo Comparator
A single dose of placebo administered by SC injection.
干预措施: Placebo (Drug)
Part B: ALN-XDH Single Dose
Experimental
A single dose of ALN-XDH administered by SC injection.
干预措施: ALN-XDH (Drug)
Part B: ALN-XDH Multiple Dose
Experimental
Multiple doses of ALN-XDH administered by SC injection.
干预措施: ALN-XDH (Drug)
Part B: Placebo
Placebo Comparator
Multiple doses of placebo administered by SC injection.
干预措施: Placebo (Drug)
Part C: ALN-XDH
Experimental
A single dose of ALN-XDH administered by SC injection.
干预措施: ALN-XDH (Drug)
Part C: Placebo
Placebo Comparator
A single dose of placebo administered by SC injection.
干预措施: Placebo (Drug)
结局指标
主要结局
Parts B and C: Frequency of Adverse Events
时间窗: Up to 14 months
Parts B and C: Percentage of Participants with Serum Uric Acid (sUA) <6 mg/dL
时间窗: Up to 12.25 months
Part A: Frequency of Adverse Events
时间窗: Up to 10 months
次要结局
- Parts B and C: Percentage of Participants with sUA <5 mg/dL(Up to 12.25 months)
- Parts B and C: Percent Change from Baseline in 24-hour Urine Uric Acid (uUA)(Baseline through Month 6)
- Parts B and C: Percent Change from Baseline in Serum Xanthine(Baseline through Month 6)
- Part A: Percent Change from Baseline in sUA(Baseline through Month 9)
- Part A: Area Under the Plasma Concentration-time Curve (AUC) for ALN-XDH and Potential Metabolites(Day 1 predose and up to 48 hours postdose)
- Part A: Time to Maximum Plasma Concentration (tmax) for ALN-XDH and Potential Metabolites(Day 1 predose and up to 48 hours postdose)
- Parts B and C: Frequency of Treatment-associated Gout Flares(Up to 6 months)
- Parts B and C: Percent Change from Baseline in 24-hour Urine Xanthine(Baseline through Month 6)
- Part A: Fractional Excreted in Urine (fe) for ALN-XDH and Potential Metabolites(Day 1 predose and up to 24 hours postdose)
- Part A: Maximum Plasma Concentration (Cmax) for ALN-XDH and Potential Metabolites(Day 1 predose and up to 48 hours postdose)
- Parts B and C: Percentage Change from Baseline in sUA Level(Up to 12.25 months)
- Parts B and C: Plasma Concentrations of ALN-XDH and Potential Major Metabolite(s)(Day 1 and Day 85 predose and up to 4 hours postdose)
- Parts B and C: Percent Change from Baseline in Serum Hypoxanthine(Baseline through Month 6)
- Parts B and C: Percent Change from Baseline in 24-hour Urine Hypoxanthine(Baseline through Month 6)
研究者
研究点 (1)
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