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

NCT06839235 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2026-02-12

No results posted yet for this study

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

DRUG

ABO-101

Intravenous (IV) infusion

Sponsors & Collaborators

  • Arbor Biotechnologies

    lead INDUSTRY

Principal Investigators

  • Winston Yan, MD, PhD · Arbor Biotechnologies

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
6 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-16
Primary Completion
2029-03-31
Completion
2043-02-28
FDA Drug
Yes

Countries

  • United States
  • France
  • Germany
  • Tunisia
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06839235 on ClinicalTrials.gov