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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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X-linked Hypophosphatemic Rickets/Osteomalacia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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KRN23

Single SC administration on day 1

Group Type EXPERIMENTAL

KRN23

Intervention Type DRUG

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

Interventions

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KRN23

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No