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
Overview
- Phase
- Phase 1
- Intervention
- Sequence 1
- Conditions
- Upper Limb Spasticity
- Sponsor
- JHM BioPharma (Tonghua) Co. , Ltd.
- Enrollment
- 84
- Locations
- 20
- Primary Endpoint
- The incidence rate of adverse events and severe adverse events
- Status
- Completed
- Last Updated
- 8 months ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Experimental Group 1
Participants will receive one cycle of JHM03 in the selected overactive upper limb muscles
Intervention: Sequence 1
Experimental Group 2
Participants will receive one cycle of JHM03 in the selected overactive upper limb muscles
Intervention: Sequence 2
Experimental Group 3
Participants will receive one cycle of JHM03 in the selected overactive upper limb muscles
Intervention: Sequence 3
Experimental Group 4
Participants will receive one cycle of JHM03 in the selected overactive upper limb muscles
Intervention: Sequence 4
Placebo Group
Participants will receive one cycle of Placebo in the selected overactive upper limb muscles
Intervention: Sequence 5
Outcomes
Primary Outcomes
The incidence rate of adverse events and severe adverse events
Time Frame: Within 12 weeks
The incidence rate of adverse events and severe adverse events within 12 weeks after injection;
Change from baseline at week 4 for primary targeted muscle group on the MAS
Time Frame: Within 4 weeks
Change from baseline at week 4 for primary targeted muscle group on the MAS(Modified Ashworth Scale).