Phase 1/2 Study of ABO-101 in Primary Hyperoxaluria Type 1 (redePHine)
Recruiting
Phase 1
Phase 2
Interventional Study
Primary Hyperoxaluria Type 1 (PH1)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 6 – 64
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 23 (estimated)
- Sponsor
- Arbor Biotechnologies · Industry
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About This Trial
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, pedia…
Trial Locations
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Eligibility 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 infor…
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