NCT07478822

A Study on Recombinant Botulinum Toxin Type A (YY001) for Injection in Multiple Treatments of Adult Upper Limb Spasticity

An Open-label, Multicenter Clinical Study on The Long-term Safety and Efficacy of Multiple Treatments With Recombinant Botulinum Toxin Type A (YY001) for Injection in Adult Upper Limb Spasticity (REHAB-2)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Chongqing Claruvis Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multicenter, phase III clinical study to evaluate the long-term safety and efficacy of multiple treatments with recombinant botulinum toxin type A (YY001) for injection in adult upper limb spasticity

Conditions

• Upper Limb Spasticity

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant botulinum toxin type A for injection (YY001)	Prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection, the total injection dose for single treatment is 200 to 400 U.

Timeline

• Start date: 2026-03-27
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2026-03-18
• Last updated: 2026-04-02

Locations

16 sites across 1 country: China