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

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 6 to 7v8
  2. Study sites: 4 to 6v7
  3. Study sites: 2 to 4
    • Start date changed from estimate of Jun 2025 to Jun 16, 2025
    v6
  4. Site contacts updated at 1 of 2 sitesv5
  5. Start date: Apr 2025 to Jun 2025
    • Study sites: 1 to 2
    v4
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  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Mar 2025 to Apr 2025
    • Site details revised
    v3
  2. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06839235
Lead Sponsor Arbor Biotechnologies
Conditions
(from sponsor)		 Primary Hyperoxaluria Type 1 (PH1)
Related terms Hyperoxaluria, Primary, Primary hyperoxaluria type 1
Enrollment 23 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov