NCT02181764已完成1 期
A Phase 1, Multicenter, Open-label, Sequential Dose-escalation, Single-dose Study to Assess the Safety and Tolerability of KRN23 in Subjects With X-linked Hypophosphatemic Rickets/Osteomalacia.
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
- 15
- 主要终点
- Number and types of adverse events
研究概览
简要总结
The objective of this study is to assess the safety and tolerability of KRN23 after a single subcutaneous (SC) administration in subjects with X-linked hypophosphatemic rickets/osteomalacia (XLH) in Japan or Korea.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Patients with XLH
排除标准
- •Have an active infection or chronic inflammatory disease
- •Have uncontrolled hypertension
- •Have uncontrolled diabetes mellitus
- •History of known immunodeficiency
- •Use of a pharmacologic vitamin D metabolite or its analogs within 21 days prior to screening and after screening
- •Use of phosphate, calcium preparation, calcimimetics, aluminum hydroxide antacids, thiazide diuretic, acetazolamide, or phosphate, calcium, and/or vitamin D-containing supplements within 10 days prior to screening and after screening
- •Pregnant or lactating females, women who are possibly pregnant or patients who have no intention of utilizing adequate contraception
研究组 & 干预措施
KRN23
Experimental
Single SC administration on day 1
干预措施: KRN23 (Drug)
结局指标
主要结局
Number and types of adverse events
时间窗: Up to 7 weeks after dosing
The safety of KRN23 assessed by number and types of adverse events, laboratory tests
次要结局
- Profiles of pharmacokinetics(Pre-dose, 24, 48, 96, 168, 336, 504, 672, 840, 1176 hours post-dose)
研究者
相似试验
已完成
1 期
A Study of KRN23 in X-linked HypophosphatemiaX-linked HypophosphatemiaNCT00830674Kyowa Kirin Co., Ltd.42
已完成
4 期
Study to Assess the Safety, Pharmacokinetics and Efficacy of KRN23 in Adult Chinese Patients With TIOTumor-Induced Osteomalacia (TIO)NCT05357573Kyowa Kirin Co., Ltd.9
已完成
4 期
Study to Assess the Safety, Pharmacokinetics and Efficacy of KRN23 in Adult Chinese Patients With XLHX-linked Hypophosphatemia (XLH)NCT04842019Kyowa Kirin Co., Ltd.18
已完成
2 期
Long-Term Extension Study of KRN23 in Adult Subjects With X-Linked Hypophosphatemia (XLH)X-Linked HypophosphatemiaNCT02312687Kyowa Kirin, Inc.20
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