RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1/2 Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of ABO-101 in Participants With Primary Hyperoxaluria Type 1 (PH1)

Quick Facts

Study Start:2025-04
Study Completion:2043-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06839235

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 64 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Daniel Ory, MD
CONTACT
617-500-8941
arbortrials@arbor.bio

Principal Investigator

Winston Yan, MD, PhD
STUDY_DIRECTOR
Arbor Biotechnologies

Study Locations (Sites)

Nucleus Network
St. Paul, Minnesota, 55114
United States

Collaborators and Investigators

Sponsor: Arbor Biotechnologies

  • Winston Yan, MD, PhD, STUDY_DIRECTOR, Arbor Biotechnologies

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04
Study Completion Date2043-02

Study Record Updates

Study Start Date2025-04
Study Completion Date2043-02

Terms related to this study

Keywords Provided by Researchers

  • PH1
  • Primary hyperoxaluria
  • AGXT
  • CRISPR
  • Gene Editing
  • Pharmacokinetics
  • Pharmacodynamics
  • ABO-101
  • redePHine

Additional Relevant MeSH Terms

  • Primary Hyperoxaluria Type 1 (PH1)