NCT06839235

Phase 1/2 Study of ABO-101 in Primary Hyperoxaluria Type 1 (redePHine)

A Phase 1/2 Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of ABO-101 in Participants With Primary Hyperoxaluria Type 1 (PH1)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 23 (estimated)
• Sponsor: Arbor Biotechnologies · Industry
• Sex: All
• Age: 6 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Hyperoxaluria Type 1 (PH1)

Interventions

Type	Name	Description
DRUG	ABO-101	Intravenous (IV) infusion

Timeline

• Start date: 2025-06-16
• Primary completion: 2029-03-01
• Completion: 2043-02-01
• First posted: 2025-02-21
• Last updated: 2026-02-12

Locations

7 sites across 5 countries: United States, France, Germany, Tunisia, United Kingdom

Regulatory

• FDA-regulated drug study