NCT00830674已完成1 期
A Phase I, Double-blind, Randomized, Placebo-controlled, Single-dose, Dose-escalation Study of KRN23 in X-linked Hypophosphatemia
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 4
- 主要终点
- Safety and tolerability
研究概览
简要总结
The primary objective of this study is to assess the safety and tolerability of KRN23 after a single intravenous (IV) and subcutaneous (SC) administration in XLH patients.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Clinical diagnosis of XLH
- •TmP/GFR is less than 2.0 mg/dL
- •GFR is 60 mL/min or above
排除标准
- •Have any sign of active infectious disease or have had an infection requiring treatment with antibiotics within three weeks prior to screening
- •History of known immunodeficiency
- •Lactating females, female patients who are pregnant or planning to become pregnant during the study
- •Use of a pharmacologic vitamin D metabolite or its analog, phosphate, calcimimetics, and ingestion of aluminum hydroxide antacids within 10 days prior to screening and dosing
- •Use of any supplement contained phosphate, calcium and/or vitamin D within 10 days prior to screening and dosing
- •Receipt of live (attenuated) vaccine within 3-months prior to screening
- •Have any condition which, in the opinion of the Investigator, could present a concern for either patient safety or difficulty with data interpretation
研究组 & 干预措施
KRN23
Experimental
Single IV or SC administration on day 1
干预措施: KRN23 (Drug)
Placebo
Placebo Comparator
Single IV or SC administration on day 1
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: Up to 7 weeks after dosing (maximally 11 weeks)
AEs, etc
次要结局
- Effect to pharmacodynamic parameter(Up to 7 weeks after dosing (maximally 11 weeks))
研究者
研究点 (4)
Loading locations...
相似试验
已完成
1 期
A Study of KRN23 in Subjects With X-linked Hypophosphatemic Rickets/OsteomalaciaX-linked Hypophosphatemic Rickets/OsteomalaciaNCT02181764Kyowa Kirin Co., Ltd.15
已完成
3 期
Open Label Study of KRN23 on Osteomalacia in Adults With X-linked Hypophosphatemia (XLH)X-linked HypophosphatemiaNCT02537431Kyowa Kirin, Inc.14
已完成
1 期
Safety, Tolerability and Pharmacokinetic Study of KL1333 in Healthy Male VolunteersMELAS SyndromeMitochondrial Respiratory Chain DeficienciesNCT03056209Yungjin Pharm. Co., Ltd.60
已完成
1 期
Dose Escalation Study of KB001 in Cystic Fibrosis Patients Infected With Pseudomonas AeruginosaCystic FibrosisNCT00638365Humanigen, Inc.27
已完成
3 期
A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic MelanomaMelanomaNCT03635983Bristol-Myers Squibb783