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RecruitingPhase 1/Phase 2

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

Arbor Biotechnologies · NCT06839235

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 6–64 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1, Phase 2
Target enrollment
23
US sites recruiting
1
Study start
June 16, 2025
Record last updated
October 19, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: ABO-101

Conditions: Primary Hyperoxaluria Type 1 (PH1)

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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)

Recruiting US locations

  • Mayo Clinic

    Rochester, MN 55905

    Site contact: Clinical Trial Site · 800-664-4542

Study contacts (from the official record)

  • Daniel Ory, MD · 617-500-8941 · arbortrials@arbor.bio
All phase 1 studies in Minnesota →
Phase 1/2 Study of ABO-101 in Primary Hyperoxaluria Type 1 (redePHine) (NCT06839235) | Bored Studies