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

X-linked Hypophosphatemic Rickets/Osteomalacia Clinical Trial

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 Rickets/Osteomalacia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02181764
• Other study ID #: KRN23-001
• Status: Completed
• Phase: Phase 1
• First received: July 2, 2014
• Last updated: February 28, 2017
• Start date: July 2014
• Est. completion date: June 2015

Study information

• Verified date: February 2017
• Source: Kyowa Hakko Kirin Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Familial Hypophosphatemic Rickets
• Osteomalacia
• Rickets
• X-linked Hypophosphatemic Rickets/Osteomalacia

Intervention

Drug:
• KRN23
Single SC administration on day 1: 0.3, 0.6 and 1.0 mg/kg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Hakko Kirin Co., Ltd

Countries where clinical trial is conducted

Japan,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and types of adverse events	The safety of KRN23 assessed by number and types of adverse events, laboratory tests	Up to 7 weeks after dosing
Secondary	Profiles of pharmacokinetics		Pre-dose, 24, 48, 96, 168, 336, 504, 672, 840, 1176 hours post-dose