A Phase 1 study of KRN23

JRCT ID: jRCT2080222550

Registered date:02/07/2014

Basic Information

• Health condition(s) or Problem(s) studied: X-linked Hypophosphatemic Rickets/Osteomalacia
• Date of first enrollment: 02/07/2014
• Target sample size: 15
• Study type: Interventional

Intervention(s)

investigational material(s)
Generic name etc : KRN23
INN of investigational material :
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Investigational material : Single SC administration on day 1

Outcome(s)

Primary Outcome

Safety
Adverse events, laboratory tests

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: 1. Patients with XLH

Exclude 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, or its 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 Information

• Primary Sponsor: Kyowa Hakko Kirin Co., Ltd.
• Secondary ID(s): JapicCTI-142601