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

NCT06783114 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2026-01-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Chongqing Claruvis Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Xinhua Wan · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-14
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT06783114 on ClinicalTrials.gov