CompletedPhase 1

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

Japan, South Korea15 participantsStarted 2014-07

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 18 years or older
✓. Patients with XLH

Exclusion criteria

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

What they're measuring

Number and types of adverse events

Timeframe: Up to 7 weeks after dosing

Trial details

NCT IDNCT02181764

SponsorKyowa Kirin Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-06

View on ClinicalTrials.gov More X-linked Hypophosphatemic Rickets/Osteomalacia trials