Phase I Exploratory Study of YOLT-203 in Patients With Primary Hyperoxaluria Type 1 (PH1)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age6+
SponsorYolTech Therapeutics Co., Ltd
About this trial
This is a single-arm, open-label, single-dose dose-escalation study. It aims to evaluate the safety and tolerability of YOLT-203 in Chinese patients with Primary Hyperoxaluria Type 1 (PH1), and to preliminarily assess the effect of a single administration of YOLT-203 on 24-hour urinary oxalate excretion.
The clinical trial will first evaluate the safety and tolerability in adult patients. After the safety profile is preliminarily confirmed, the trial will be sequentially conducted in adolescents, older children, and younger children.
Eligibility criteria
Qualifiers
None
Disqualifiers
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 × upper limit of normal (ULN).
Total bilirubin > 1.5 × ULN. Subjects diagnosed with Gilbert syndrome whose total bilirubin < 2 × ULN may be enrolled.
International normalized ratio (INR) > 1.5 (subjects taking oral anticoagulants such as warfarin with INR < 3.5 are allowed to participate).
Trial design
Treatments tested in this trial
- YOLT-203
Treatment groups
9 Participants
are divided into 1 treatment groupSponsors and collaborators
YolTech Therapeutics Co., Ltd
Lead sponsor
RenJi Hospital
Collaborator
Source ClinicalTrials.gov