A first-in-human study of KK8123 in adults with X-linked hypophosphatemia
Research type
Research Study
Full title
A Multicenter, Open-label, Phase 1/2, Dose-escalation and Subsequent Safety Extension Study of Subcutaneous KK8123 in Adult Patients with X-linked Hypophosphatemia.
IRAS ID
1009715
Contact name
Rowitha Reisinger
Contact email
Sponsor organisation
Kyowa Kirin, Inc.
Eudract number
2023-509390-23
Research summary
The purpose of this study is to test the safety and effectiveness of an investigational drug called KK8123. KK8123 is given as a subcutaneous (under the skin) injection and is expected to stop the action of fibroblast growth factor 23 (FGF23) and thereby normalise blood phosphorus levels, which may help improve XLH symptoms
REC name
South Central - Oxford A Research Ethics Committee
REC reference
24/SC/0282
Date of REC Opinion
12 Nov 2024
REC opinion
Further Information Favourable Opinion