A Clinical Study to Evaluate the Safety and Efficacy of JHM03 in Adult Patients With Upper Limb Spasticity
A Phase Ib/II Clinical Study to Evaluate the Safety and Efficacy of Recombinant Botulinum Toxin Type A (JHM03) in Adult Patients With Upper Limb Spasticity
1 other identifier
interventional
84
1 country
20
Brief Summary
This is a phase Ib/II clinical study to evaluate the safety and efficacy of recombinant botulinum toxin type A（JHM03）in adult patients with upper limb spasticity. The purpose of this study was to observe efficacy and safety of JHM03 compared with placebo in adult patients with upper limb spasticity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2024
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 2, 2024
CompletedFirst Posted
Study publicly available on registry
September 4, 2024
CompletedStudy Start
First participant enrolled
September 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 24, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 23, 2025
CompletedSeptember 2, 2025
August 1, 2025
8 months
September 2, 2024
August 25, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
The incidence rate of adverse events and severe adverse events
The incidence rate of adverse events and severe adverse events within 12 weeks after injection;
Within 12 weeks
Change from baseline at week 4 for primary targeted muscle group on the MAS
Change from baseline at week 4 for primary targeted muscle group on the MAS(Modified Ashworth Scale).
Within 4 weeks
Study Arms (5)
Experimental Group 1
EXPERIMENTALParticipants will receive one cycle of JHM03 in the selected overactive upper limb muscles
Experimental Group 2
EXPERIMENTALParticipants will receive one cycle of JHM03 in the selected overactive upper limb muscles
Experimental Group 3
EXPERIMENTALParticipants will receive one cycle of JHM03 in the selected overactive upper limb muscles
Experimental Group 4
EXPERIMENTALParticipants will receive one cycle of JHM03 in the selected overactive upper limb muscles
Placebo Group
PLACEBO COMPARATORParticipants will receive one cycle of Placebo in the selected overactive upper limb muscles
Interventions
Single treatment, intramuscularly injected. The total injection 100-150U.
Single treatment, intramuscularly injected. The total injection 200-250U.
Single treatment, intramuscularly injected. The total injection 350-400U.
Single treatment, intramuscularly injected. The total injection ≤400U.
Eligibility Criteria
You may qualify if:
- Participant must be 18 to 80 years of age inclusive, at the time of signing the informed consent
- Body weight ≥50Kg
- Participants with stable post-stroke Spasticity (ULS) for at least 3 months
- Participants with Modified Ashworth Scale (MAS) score of at least 2 at elbow flexor or wrist flexor or finger flexor
- Participants with DAS score of at least 2 on the Principal Target of Treatment (PTT) (one of four functional domains: dressing, hygiene, limb position and pain)
- Participants who have been stable for at least 1 month prior to study entry in terms of oral antispasticity
You may not qualify if:
- Previous use of any botulinum toxin within 6 months prior to screening, or plan to use any botulinum toxin during the study.
- History of alcohol or drug abuse.
- Known allergy or hypersensitivity to any component of the study products.
- History of epilepsy
- Known or suspected to be HIV positive, serologically positive for syphilis, or active hepatitis B or C
- Any medical condition that may put the participant at increased risk for botulinum toxin type A use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Zhujiang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Huazhong University of Science and Technology Union Hospital
Shenzhen, Guangdong, China
The Second Hospital of Hebei Medical Hospital
Shijiazhuang, Hebei, China
Luoyang Central Hospital
Luoyang, Henan, China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Huai 'an Second People's Hospital
Huai'an, Jiangsu, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, China
Shengjing Hospital affiliated to China Medical University
Shenyang, Liaoning, China
Rizhao People's Hospital
Rizhao, Shandong, China
Yantai Mountain Hospital
Yantai, Shandong, China
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 200040, China
Yangzhi Affiliated Rehabilitation Hospital of Tongji University
Shanghai, Shanghai Municipality, China
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double-blinded
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2024
First Posted
September 4, 2024
Study Start
September 14, 2024
Primary Completion
May 24, 2025
Study Completion
July 23, 2025
Last Updated
September 2, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share