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
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

A first-in-human study of KK8123 in adults with X-linked hypophosphatemia.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Part 1: Inclusion Criteria:

‣ 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.

Locations
United States
California
University of California - San Francisco
RECRUITING
San Francisco
Connecticut
Yale Center for XLH/ Yale University School of Medicine
RECRUITING
New Haven
Indiana
Indiana University School of Medicine University Hospital
RECRUITING
Indianapolis
Minnesota
Mayo Clinic
NOT_YET_RECRUITING
Rochester
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Other Locations
France
Hoptial Bictre
RECRUITING
Le Kremlin-bicêtre
Germany
Institute of Osteology and Biomechanics (IOBM)
RECRUITING
Hamburg
Universitaetsklinikum Wurzburg
RECRUITING
Würzburg
Spain
Hospital Universitario La Paz
RECRUITING
Madrid
Contact Information
Primary
Kyowa Kirin
KKD.Clintrial.82@kyowakirin.com
609-919-1100
Time Frame
Start Date: 2024-10-09
Estimated Completion Date: 2028-05-10
Participants
Target number of participants: 24
Treatments
Experimental: Part I: Cohort 1
Low Dose, single dose of KK8123
Experimental: Part I: Cohort 2
Mild dose, multiple doses of KK8123
Experimental: Part I: Cohort 3
High dose, multiple doses of KK8123
Experimental: Part I: Cohort 4
Optional, multiple doses of KK8123
Experimental: Part 2: Extension Period
High dose, multiple doses as confirmed for Cohort 3 of KK8123.
Sponsors
Leads: Kyowa Kirin Co., Ltd.
Collaborators: Kyowa Kirin, Inc.

This content was sourced from clinicaltrials.gov