Status:
RECRUITING
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Collaborating Sponsors:
Kyowa Kirin, Inc.
Conditions:
X-linked Hypophosphatemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
A first-in-human study of KK8123 in adults with X-linked hypophosphatemia.
Detailed Description
Study 8123-001 is a Phase 1/2, multicenter, open-label, dose-escalation study to assess the safety, tolerability, PK and PD of KK8123, with an optional safety extension period. This study is comprised...
Eligibility Criteria
Inclusion
- Part 1:
- 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.
- Have a value of renal TmP/GFR \< 2.5 mg/dL (0.81 mmol/L) at Screening.
- eGFR ≥ 60 mL/min (using the Chronic Kidney Disease Epidemiology Collaboration equation \[Inker, 2021\]) at Screening.
- Have a corrected serum calcium level \< 10.8 mg/dL (2.7 mmol/L) at Screening.
- Provide a signed ICF.
- Agree not to change diet and exercise regimen from one week prior to dosing to end of study.
- Have a negative pregnancy test at Screening and be willing to have additional pregnancy tests during the study (female participants only).
- If taking chronic pain medications (including narcotic pain medications/opioids), must be on a stable regimen for at least 21 days prior to the Screening visit, and be willing to maintain medications at the same stable dose(s) and schedule throughout the clinical trial. The dose must not exceed 60 mg oral morphine equivalents/day.
- Be willing to use a method of contraception following local country guidelines while participating in the study and for 5 months after the last dose (all sexually active participants of childbearing potential).
- Women of non-childbearing potential are defined as permanently sterile (i.e., due to tubal ligation at least one year before Screening, hysterectomy or bilateral oophorectomy) or postmenopausal (defined as at least 12 months post cessation of menses without an alternative medical cause).
- Postmenopausal status of female participants will be confirmed with a Screening serum follicle-stimulating hormone level \>40 mIU/mL.
- Must, in the opinion of the investigator, be willing and able to complete all aspects of the study, adhere to the study visit schedule and comply with the assessments.
Exclusion
- Part 1:
Key Trial Info
Start Date :
October 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 10 2028
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06525636
Start Date
October 9 2024
End Date
May 10 2028
Last Update
November 14 2025
Active Locations (9)
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1
University of California - San Francisco
San Francisco, California, United States, 94158
2
Yale Center for XLH/ Yale University School of Medicine
New Haven, Connecticut, United States, 06510
3
Indiana University School of Medicine University Hospital
Indianapolis, Indiana, United States, 46202
4
Mayo Clinic
Rochester, Minnesota, United States, 55905