A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
Part of paid clinical trials in San Francisco, California.
- Sponsor
- Kyowa Kirin Co., Ltd.
- Study ID
- NCT06525636
- Phase
- PHASE1/PHASE2
- Status
- Recruiting
Conditions
- X-linked Hypophosphatemia
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- KK8123 — DRUGSubcutaneous administration
Study Details
A first-in-human study of KK8123 in adults with X-linked hypophosphatemia.
Key Dates
- First listed
- Jul 29, 2024
- Start date
- Oct 9, 2024
- Status verified
- Nov 2025
- Primary completion
- Feb 11, 2028
- Completion
- May 10, 2028
Study Design
- Enrollment
- 24 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Part I: Cohort 1Low Dose, single dose of KK8123
- Experimental: Part I: Cohort 2Mild dose, multiple doses of KK8123
- Experimental: Part I: Cohort 3High dose, multiple doses of KK8123
- Experimental: Part I: Cohort 4Optional, multiple doses of KK8123
- Experimental: Part 2: Extension PeriodHigh dose, multiple doses as confirmed for Cohort 3 of KK8123.
Primary Outcome Measure
Part 1: Number of participants with TEAEs [ Time Frame: For up to 44 weeks. ]
Central Contacts
- Kyowa Kirin609-919-1100
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of California - San Francisco | San Francisco | California | 94158 | Farzana Perwad, MD (PRINCIPAL_INVESTIGATOR) |
| Yale Center for XLH/ Yale University School of Medicine | New Haven | Connecticut | 06510 | Clemens Bergwitz, MD (PRINCIPAL_INVESTIGATOR) |
| Indiana University School of Medicine University Hospital | Indianapolis | Indiana | 46202 | Erik Imel, MD (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic | Rochester | Minnesota | 55905 | - |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | Kathryn Dahir, MD (PRINCIPAL_INVESTIGATOR) |