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

NCT07587021 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-05-14

No results posted yet for this study

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.

Conditions

  • Primary Hyperoxaluria Type 1
  • PH1

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.

Sponsors & Collaborators

  • YolTech Therapeutics Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Ling Xiao, MD, PhD · YolTech Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-08-31
Completion
2028-02-29
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07587021 on ClinicalTrials.gov