A Phase II Study on Recombinant Botulinum Toxin Type a (YY001) for Injection in the Treatment of Upper Limb Spasticity in Adults

PHASE2RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

September 14, 2024

Primary Completion Date

March 18, 2025

Study Completion Date

May 16, 2025

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 U (low dose cohort)/ 300 U (medium dose cohort)/ 400 U (high dose cohort).

BIOLOGICAL

BOTOX®

Single treatment, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection, the total injection dose is 200 U (low dose cohort).

BIOLOGICAL

Placebo

Single treatment, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), intramuscular injection.

Trial Locations (19)

Unknown

RECRUITING

Anhui Provincial Hospital, Hefei

RECRUITING

The Second People's Hospital of Hefei, Hefei

RECRUITING

Peking Union Medical College Hospital, Beijing

RECRUITING

Guangdong Provincial People's Hospital, Guangzhou

RECRUITING

Sun Yat-sen Memorial Hospital, Guangzhou

RECRUITING

Shenzhen Second People's Hospital, Shenzhen

RECRUITING

The First Affiliated Hospital of Henan University, Kaifeng

RECRUITING

RenMin Hospital Of Wuhan University, Wuhan

RECRUITING

The First Affiliated Hospital of Soochow University, Suzhou

RECRUITING

Xuzhou Medical University Affiliated Hospital, Xuzhou

RECRUITING

Qilu Hospital of Shandong University, Qingdao

RECRUITING

Rui Jin Hospital of Shanghai Jiao Tong University School of Medicine, Shanghai

RECRUITING

Shanghai Fudan University HuaShan Hospital, Shanghai

RECRUITING

Yangzhi Affiliated Rehabilitation Hospital of Tongji University, Shanghai

RECRUITING

Shanxi Bethune Hospital, Taiyuan

RECRUITING

Shanxi provincial people's Hospital, Taiyuan

RECRUITING

West China Hospital,Sichuan University, Chengdu

RECRUITING

Tianjin Medical University General Hospital, Tianjin

RECRUITING

The Second Affiliated Hospital of Kunming Medical University, Kunming

All Listed Sponsors
lead

Chongqing Claruvis Pharmaceutical Co., Ltd.

INDUSTRY