Phase 1/2 Study of ABO-101 in Primary Hyperoxaluria Type 1 (redePHine)
Recruiting now · Phase 1/Phase 2
Conditions studied: Primary Hyperoxaluria Type 1 (PH1)
In brief
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.
Key facts
- Study ID
- NCT06839235
- Run by
- Arbor Biotechnologies
- People needed
- 23
- Starts
- 2025-06-16
- Expected to finish
- 2043-02-01
- Last updated by the study team
- 2026-02-12
Who can join
Age: 6 and older, up to 64. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Heidi Chaker — Sfax, Tunisia (enrolling)
- Queen Elizabeth Hospital Birmingham — Birmingham, United Kingdom (enrolling)
- Royal Free Hospital — London, United Kingdom (enrolling)
- Mayo Clinic — Rochester, Minnesota, United States (enrolling)
- Kindernierenzentrum Bonn — Bonn, Germany
- Nucleus Network — Saint Paul, Minnesota, United States
- Hospices Civils de Lyon- Hôpital Femmes Mères Enfants — Lyon, France
Full record on ClinicalTrials.gov
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