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

Phase 1

Completed

• Conditions: X-linked Hypophosphatemic Rickets/Osteomalacia
• Interventions: Drug: KRN23

• Registration Number: NCT02181764
• Lead Sponsor: Kyowa Kirin Co., Ltd.

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 Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-02
• Study First Submitted QC: 2014-07-02
• Study First Posted: 2014-07-04
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. 18 years or older
2. Patients with XLH

Exclusion Criteria

1. Have an active infection or chronic inflammatory disease
2. Have uncontrolled hypertension
3. Have uncontrolled diabetes mellitus
4. History of known immunodeficiency
5. Use of a pharmacologic vitamin D metabolite or its analogs within 21 days prior to screening and after screening
6. 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
7. Pregnant or lactating females, women who are possibly pregnant or patients who have no intention of utilizing adequate contraception

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
KRN23	KRN23	Single SC administration on day 1

Primary Outcome Measures

Name	Time	Method
Number and types of adverse events	Up to 7 weeks after dosing	The safety of KRN23 assessed by number and types of adverse events, laboratory tests

Secondary Outcome Measures

Name	Time	Method
Profiles of pharmacokinetics	Pre-dose, 24, 48, 96, 168, 336, 504, 672, 840, 1176 hours post-dose