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YQ23 Study in Patients With Critical Limb Ischaemia

NCT04792008 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2023-12-08

No results posted yet for this study

Summary

This is an early phase study to assess how safe and tolerable is the new study drug YQ23 and to compare the effectiveness of YQ23 against normal saline to treat critical limb ischaemia. The study also aims to understand how it affects the body and an optional substudy to assess how the human body takes up, breaks down, and clears the study drug.

Eligible patients will be randomised to have a 2:1 chance to receive a single, intravenous, fixed dose of YQ23 or normal saline. Neither the patient nor the study site will know which treatment has been given.

On the day of YQ23 administration, patients will be asked to stay in the study site for 3 days for safety observation. After discharge, they will be required to visit the study clinic for 3 times in a year to continue safety monitoring and assessment of treatment effect.

Each subject's participation will be about 13 months after signing the informed consent.

Conditions

  • Critical Limb Ischemia

Interventions

BIOLOGICAL

YQ23

Single dose of 120 mg/kg YQ23 via intravenous route will be evaluated

BIOLOGICAL

Matching placebo

Single dose of 0.9% normal saline via intravenous route as matching placebo

Sponsors & Collaborators

  • New Beta Innovation Limited

    lead INDUSTRY

Principal Investigators

  • Billy Lau · New Beta Innovation Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-10
Primary Completion
2023-08-31
Completion
2023-08-31

Countries

  • Hong Kong

Study Locations

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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 NCT04792008 on ClinicalTrials.gov