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Clinical Trials in France / NCT06839235
Recruiting Phase 1/2

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

NCT06839235 · tracked via the Priya Life Science France tracker
Sponsor
Arbor Biotechnologies
Phase
Phase 1/2
Started
2025-06-16
Last updated
2026-10-19

Condition(s) studied

Primary Hyperoxaluria Type 1 (PH1)

Investigational drug(s) / intervention(s)

ABO-101

ABO-101: Intravenous (IV) infusion

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.

Eligibility

Sex
ALL
Min age
6 Years
Max age
64 Years
Healthy volunteers
No
Key Inclusion Criteria for Parts A and B * Documentation of PH1 as determined by genetic analysis confirming pathogenic mutations in the alanine-glyoxylate aminotransferase (AGXT) gene (valid historical laboratory data will be reviewed and approved by the Sponsor) * Age at time of signing the informed consent/assent form: * Part A: ≥18 years to ≤64 years * Part B: ≥6 years to \<18 years * 24-hour UOx ≥0.7 mmol/24 hours/1.73 m² * eGFR ≥30 mL/min/1.73m² * Weight ≤90 kg Key Exclusion Criteria for Parts A and B * Confirmed diagnosis of primary hyperoxaluria type 2 or type 3 * History of a liver, kidney or combined liver/kidney transplant * Currently on dialysis * Participant has previously used (within past 24 months) or is currently receiving an approved or investigational urinary oxalate lowering RNA interference (RNAi) or siRNA therapy * Female participants who are pregnant or breastfeeding (or are planning either during the first 12 months)

Primary outcome measure(s)

  • Incidence and severity of treatment-emergent adverse events (TEAEs), including ABO-101-related TEAEs and serious adverse events (SAEs) — Up to 6 months

Trial sites (7)

FacilityCityRegionStatus
Mayo Clinic Rochester Minnesota Recruiting
Nucleus Network Saint Paul Minnesota Withdrawn
Hospices Civils de Lyon- Hôpital Femmes Mères Enfants Lyon France Not Yet Recruiting
Kindernierenzentrum Bonn Bonn Germany Not Yet Recruiting
Heidi Chaker Sfax Tunisia Recruiting
Queen Elizabeth Hospital Birmingham Birmingham United Kingdom Recruiting
Royal Free Hospital London United Kingdom Recruiting

Other trials for the same condition

Long Term Extension Study in Patients With Primary Hyperoxaluria Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06839235 on ClinicalTrials.gov ↗ ← All trials in France