A Multicenter, Open-label, Phase 1/2, Dose-escalation and Subsequent Safety Extension Study of Subcutaneous KK8123 in Adult Patients with X-linked Hypophosphatemia

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509390-23-00

Acronym

8123-001

Enrollment

Registered

2024-11-11

Start date

2025-08-29

Completion date

Unknown

Last updated

2025-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

X-linked hypophosphatemia.

Brief summary

TEAEs., Laboratory values, Vital signs., 12-lead electrocardiogram., Echocardiogram., Renal ultrasound., Serum KK8123 concentrations over time and PK parameters.

Detailed description

Change in serum phosphorus levels over time., Change from baseline in serum phosphorus levels., Achieving serum phosphorus levels within the normal range through the last dosing interval., Achieving average serum phosphorus levels within the normal range across all dosing intervals., Incidence of anti-drug antibodies over time.

Interventions

DRUGKK8123

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
TEAEs., Laboratory values, Vital signs., 12-lead electrocardiogram., Echocardiogram., Renal ultrasound., Serum KK8123 concentrations over time and PK parameters.	—

Secondary

Measure	Time frame
Change in serum phosphorus levels over time., Change from baseline in serum phosphorus levels., Achieving serum phosphorus levels within the normal range through the last dosing interval., Achieving average serum phosphorus levels within the normal range across all dosing intervals., Incidence of anti-drug antibodies over time.	—

Countries

France, Germany, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026