NCT00830674

A Study of KRN23 in X-linked Hypophosphatemia

A Phase I, Double-blind, Randomized, Placebo-controlled, Single-dose, Dose-escalation Study of KRN23 in X-linked Hypophosphatemia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Kyowa Kirin Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• X-linked Hypophosphatemia

Interventions

Type	Name	Description
DRUG	Placebo	single dose IV or SC administration
DRUG	KRN23	Single IV administration on day 1: 0.003, 0.01, 0.03, 0.1 and 0.3 mg/kg and Single SC administration on day 1: 0.1, 0.3, 0.6 and 1.0 mg/kg

Timeline

• Start date: 2008-12-01
• Primary completion: 2011-12-01
• Completion: 2013-05-01
• First posted: 2009-01-28
• Last updated: 2024-06-17

Locations

4 sites across 1 country: United States