RecruitingPhase 1Phase 2NCT06839235

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)


Sponsor

Arbor Biotechnologies

Enrollment

23 participants

Start Date

Jun 16, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 6 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called ABO-101 for people with primary hyperoxaluria type 1 (ph1). The study is currently recruiting participants at 7 locations. People eligible for this study include aged 6 Years to 64 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGABO-101

Intravenous (IV) infusion


Locations(7)

Mayo Clinic

Rochester, Minnesota, United States

Nucleus Network

Saint Paul, Minnesota, 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

View Full Details on ClinicalTrials.gov

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NCT06839235