NCT06783114

A Clinical Study on Recombinant Botulinum Toxin Type A (YY001) for Injection in The Treatment of Upper Limb Spasticity in Adults

A Clinical Study to Evaluate the Efficacy and Safety of Recombinant Botulinum Toxin Type A (YY001) for Injection in The Treatment of Upper Limb Spasticity in Adults (REHAB-1)

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 254 (estimated)
• Sponsor: Chongqing Claruvis Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, multi-center phase II/III study to evaluate the efficacy and safety of Recombinant Botulinum Toxin Type A (YY001) for injection in the treatment of upper limb spasticity in adults

Conditions

• Upper Limb Spasticity

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant Botulinum Toxin Type A for injection (YY001)	Single treatment, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection, the total injection dose is 200-400 U.
BIOLOGICAL	BOTOX®	Single treatment, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection, the total injection dose is 200 U.
BIOLOGICAL	Placebo	Single treatment, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection.

Timeline

• Start date: 2024-09-14
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2025-01-20
• Last updated: 2026-01-22

Locations

24 sites across 1 country: China