YQ23 Study in Patients With Critical Limb Ischaemia
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Critical Limb Ischemia
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Investigator)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is a Phase 1b/2a, randomised, double-blind, placebo-controlled study to evaluate the safety, tolerability, and efficacy of an investigational product, YQ23, in patients with Critical Limb Ischaemia (CLI) during a follow-up period of 12 months. Fifty-one patients are planned for enrolment. The s...
This is a Phase 1b/2a, randomised, double-blind, placebo-controlled study to evaluate the safety, tolerability, and efficacy of an investigational product, YQ23, in patients with Critical Limb Ischaemia (CLI) during a follow-up period of 12 months. Fifty-one patients are planned for enrolment. The study consists of a screening period (up to 28 days), a double-blind treatment period, and a follow-up (12 months). Prior to randomisation, patients diagnosed with CLI will be stratified into: Group of patients in whom revascularisation is not planned Group of patients with planned revascularisation Within each group, patients will be randomised in a 2:1 ratio to receive single intravenous infusion of YQ23 120 mg/kg and normal saline, respectively at the study site. On the day of YQ23 administration, the patient will be admitted to the study site on Day 1 and will be discharged on Day 3. The total duration of participation in the study for each patient is approximately 13 months. Data on the study endpoints will be collected from baseline (pre-dose on Day 1), Day 3, Month 1, 6 and up to 12 months after study treatment infusion.
Tracking Information
- NCT #
- NCT04792008
- Collaborators
- Not Provided
- Investigators
- Study Director: Billy Lau New Beta Innovation Limited