X-linked Hypophosphatemic Rickets/Osteomalacia
Conditions
Keywords
XLH
Brief 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.
Interventions
DRUGKRN23
Single SC administration on day 1: 0.3, 0.6 and 1.0 mg/kg
Sponsors
Kyowa Kirin Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and types of adverse events | Up to 7 weeks after dosing | The safety of KRN23 assessed by number and types of adverse events, laboratory tests |
Secondary
| Measure | Time frame |
|---|---|
| Profiles of pharmacokinetics | Pre-dose, 24, 48, 96, 168, 336, 504, 672, 840, 1176 hours post-dose |
Countries
Japan, South Korea
Outcome results
None listed