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Recruiting NCT06839235

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

Conditions: Primary Hyperoxaluria Type 1 (PH1)

Sex: All
Ages: 6 Years – 64 Years
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 23
Sponsor: Arbor Biotechnologies

Location: Mayo Clinic Rochester Minnesota

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 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 \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06839235). StuddyBuddy aggregates publicly available trial information.