Phase 1/2 Study of ABO-101 in Primary Hyperoxaluria Type 1 (redePHine)
Start Date
6/16/2025
Completion Date
2/1/2043
Summary
The goal of the redePHine study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ABO-101 in participants with primary hyperoxaluria type 1 (PH1). The trial will consist of 2 Study Periods. During the first Study Period, there will be 2 parts. In Part A, adult participants will be treated with a single ascending dose to identify a recommended dose. In Part B, pediatric participants will be treated with the recommended dose. Following the first Study Period, participants will start Study Period 2, a long-term monitoring program to comply with local and national requirements.
Eligibility Criteria
Age Range: 6 years to 64 years
Interventions
ABO-101
Conditions
Locations
Mayo Clinic
Rochester, Minnesota 55905
United States
Nucleus Network
Saint Paul, Minnesota 55114
United States
Hospices Civils de Lyon- Hôpital Femmes Mères Enfants
Lyon,
France
Kindernierenzentrum Bonn
Bonn,
Germany
Heidi Chaker
Sfax,
Tunisia
Queen Elizabeth Hospital Birmingham
Birmingham,
United Kingdom
Royal Free Hospital
London,
United Kingdom