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NOT YET RECRUITING
NCT07587021
PHASE2

Study of YOLT-203 in Children and Adults With Primary Hyperoxaluria Type 1 (PH1)

Sponsor: YolTech Therapeutics Co., Ltd

View on ClinicalTrials.gov

Summary

This study will be conducted to evaluate the efficacy and safety of YOLT-203 in children and adults with Primary Hyperoxaluria Type 1. After the initial randomized, 6-month double-blind, placebo-controlled period, participants who were initially assigned to placebo will receive a single-dose of YOLT-203 treatment whereas participants in the YOLT-203 group will receive a single-dose of placebo infusion.

Official title: A Randomized, Double-blind, Placebo-controlled Study Followed by a Treatment Extension to Evaluate the Efficacy and Safety of YOLT-203 in Children and Adults With Primary Hyperoxaluria Type 1

Key Details

Gender

All

Age Range

6 Years - Any

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2026-06

Completion Date

2028-02

Last Updated

2026-05-14

Healthy Volunteers

No

Interventions

GENETIC

YOLT-203

YOLT-203 is an investigational gene editing therapy being evaluated for the treatment of Primary Hyperoxaluria Type 1 (PH1). It is administered by intravenous infusion over 1 hour.

DRUG

Placebo

Placebo is a matching intravenous infusion administered over 1 hour.