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

Kyowa Kirin

Status and phase: Completed; Phase 1

Conditions: X-linked Hypophosphatemic Rickets/Osteomalacia

Treatments: Drug: KRN23

Study type: Interventional

Funder types: Industry

Identifiers

NCT02181764

KRN23-001

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

KRN23

Experimental group

Description:

Single SC administration on day 1

Treatment:

Drug: KRN23