A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
ConditionX-linked Hypophosphatemia
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKyowa Kirin Co., Ltd.
About this trial
A first-in-human study of KK8123 in adults with X-linked hypophosphatemia.
Eligibility criteria
Qualifiers
Male or female patients aged 18 to 65 years inclusive at the time of signing the ICF.
Body weight is at least 40 kg.
Diagnosed with XLH (as documented by the investigator).
Have a value of fasting serum phosphorus < 2.5 mg/dL (0.81 mmol/L) at Screening.
Disqualifiers
For XLH patients previously treated with burosumab, use of burosumab within 7 months prior to ICF signature.
Prior history of positive test for human immunodeficiency virus antibody, positive test for hepatitis B surface antigen, and/or hepatitis C virus antibody at Screening.
History of hypersensitivity to any ingredient of any therapeutic monoclonal antibody.
Have an active infection.
Trial design
Treatments tested in this trial
- KK8123
Treatment groups
24 Participants
are divided into 5 treatment groupsSponsors and collaborators
Kyowa Kirin Co., Ltd.
Lead sponsor
Kyowa Kirin, Inc.
Collaborator
Source ClinicalTrials.gov