Clinical Trial: A Study of KRN23 in Subjects With X-linked Hypophosphatemic Rickets/Osteomalacia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Ricket

Brief Summary: 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.

Detailed Summary:
Sponsor: Kyowa Hakko Kirin Co., Ltd

Current Primary Outcome: Number and types of adverse events [ Time Frame: Up to 7 weeks after dosing ]

The safety of KRN23 assessed by number and types of adverse events, laboratory tests


Original Primary Outcome: Same as current

Current Secondary Outcome: Profiles of pharmacokinetics [ Time Frame: Pre-dose, 24, 48, 96, 168, 336, 504, 672, 840, 1176 hours post-dose ]

Original Secondary Outcome: Same as current

Information By: Kyowa Hakko Kirin Co., Ltd

Dates:
Date Received: July 2, 2014
Date Started: July 2014
Date Completion:
Last Updated: February 28, 2017
Last Verified: February 2017