A Phase 1/2 interventional study of ABO-101 in Primary Hyperoxaluria Type 1 (PH1), sponsored by Arbor Biotechnologies. Recruiting at 7 sites in 5 countries. Open to participants aged 6 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Arbor Biotechnologies · Phase 1/2, Interventional, and Treatment
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.
22 studies on the registry are indexed under Primary hyperoxaluria type 1; 8 are open to participants now.
This study's planned enrollment of 23 is below the median of 28 across 16 interventional studies indexed under Primary hyperoxaluria type 1.
Browse Primary hyperoxaluria type 1 studies →This is the only study on the registry with Arbor Biotechnologies as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria for Parts A and B
Age at time of signing the /assent form:
Key Exclusion Criteria for Parts A and B
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: ABO-101
Drug: ABO-101
Intravenous (IV) infusion
Incidence and severity of treatment-emergent adverse events (TEAEs), including ABO-101-related TEAEs and serious adverse events (SAEs)
Time frame: Up to 6 months
Percent change in 24-hour urinary oxalate excretion (UOx) from Baseline to Month 6
Time frame: Up to 6 months
Absolute change in UOx corrected for body surface area
Time frame: Up to 6 months
Percent change in plasma glycolate from Baseline to Month 6
Time frame: Up to 6 months
Changes in estimated glomerular filtration rate (eGFR) from Baseline to Month 12 and Month 24
Time frame: Up to 24 months
Plasma concentrations for LNP lipids, Cas12i2 mRNA, and guide RNA (gRNA)
Time frame: Up to 6 months
Urine concentrations for LNP lipids
Time frame: Up to 6 months
Antidrug antibodies to ABO-101 and anti-Cas protein antibodies
Time frame: Up to 6 months
Not enrolling at this site.
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for Mar 2029, 45 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Primary hyperoxaluria type 1 →