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

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.

Study Overview

• Status: Completed
• Conditions: Upper Limb Spasticity
• Intervention / Treatment: Drug: Sequence 1; Drug: Sequence 2; Drug: Sequence 3; Drug: Sequence 4; Drug: Sequence 5

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Beijing Tsinghua Changgung Hospital
  • Gansu
    • Lanzhou, Gansu, China
      • The First Hospital of Lanzhou University
  • Guangdong
    • Guangzhou, Guangdong, China
      • The Fifth Affiliated Hospital of Guangzhou Medical University
    • Guangzhou, Guangdong, China
      • Zhujiang Hospital, Southern Medical University
    • Shenzhen, Guangdong, China
      • Huazhong University of Science and Technology Union Hospital
  • Hebei
    • Shijiazhuang, Hebei, China
      • The Second Hospital of Hebei Medical Hospital
  • Henan
    • Luoyang, Henan, China
      • Luoyang Central Hospital
    • Zhengzhou, Henan, China
      • The Second Affiliated Hospital of Zhengzhou University
  • Hubei
    • Wuhan, Hubei, China
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
    • Wuhan, Hubei, China
      • Renmin Hospital of Wuhan University
  • Hunan
    • Changsha, Hunan, China
      • The second Xiangya Hospital of Central South University
  • Jiangsu
    • Huai'an, Jiangsu, China
      • Huai 'an Second People's Hospital
    • Nanjing, Jiangsu, China
      • Jiangsu Province Hospital
    • Suzhou, Jiangsu, China
      • The Second Affiliated Hospital of Soochow University
  • Jiangxi
    • Pingxiang, Jiangxi, China
      • Pingxiang People's Hospital
  • Liaoning
    • Shenyang, Liaoning, China
      • Shengjing Hospital affiliated to China Medical University
  • Shandong
    • Rizhao, Shandong, China
      • Rizhao People's Hospital
    • Yantai, Shandong, China
      • Yantai Mountain Hospital
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200040
      • Huashan Hospital Fudan University
    • Shanghai, Shanghai Municipality, China
      • Yangzhi Affiliated Rehabilitation Hospital of Tongji University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group 1; Participants will receive one cycle of JHM03 in the selected overactive upper limb muscles	Drug: Sequence 1; Single treatment, intramuscularly injected. The total injection 100-150U.
Experimental: Experimental Group 2; Participants will receive one cycle of JHM03 in the selected overactive upper limb muscles	Drug: Sequence 2; Single treatment, intramuscularly injected. The total injection 200-250U.
Experimental: Experimental Group 3; Participants will receive one cycle of JHM03 in the selected overactive upper limb muscles	Drug: Sequence 3; Single treatment, intramuscularly injected. The total injection 350-400U.
Experimental: Experimental Group 4; Participants will receive one cycle of JHM03 in the selected overactive upper limb muscles	Drug: Sequence 4; Single treatment, intramuscularly injected. The total injection ≤400U.
Placebo Comparator: Placebo Group; Participants will receive one cycle of Placebo in the selected overactive upper limb muscles	Drug: Sequence 5; Single treatment, intramuscularly injected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: JHM BioPharma (Tonghua) Co. , Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2024
• Primary Completion (Actual): May 24, 2025
• Study Completion (Actual): July 23, 2025

Study Registration Dates

• First Submitted: September 2, 2024
• First Submitted That Met QC Criteria: September 2, 2024
• First Posted (Actual): September 4, 2024

Study Record Updates

• Last Update Posted (Estimated): September 2, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Muscle Spasticity
• Other Study ID Numbers: JHM03-CT102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No