A Phase 1 interventional study of KRN23 in X-linked Hypophosphatemic Rickets/Osteomalacia, sponsored by Kyowa Kirin Co., Ltd.. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-03.
Sponsored by Kyowa Kirin Co., Ltd. · Phase 1, Interventional, and Treatment
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.
49 studies on the registry are indexed under Familial Hypophosphatemic Rickets; 8 are open to participants now.
This study's enrollment of 15 is below the median of 28 across 29 interventional studies indexed under Familial Hypophosphatemic Rickets.
Browse Familial Hypophosphatemic Rickets studies →Kyowa Kirin Co., Ltd. is the lead sponsor of 159 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single SC administration on day 1
Drug: KRN23
Single SC administration on day 1: 0.3, 0.6 and 1.0 mg/kg
Number and types of adverse events
The safety of KRN23 assessed by number and types of adverse events, laboratory tests
Time frame: Up to 7 weeks after dosing
Profiles of pharmacokinetics
Time frame: Pre-dose, 24, 48, 96, 168, 336, 504, 672, 840, 1176 hours post-dose
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Burosumab
Familial Hypophosphatemic Rickets →