A Clinical Study to Evaluate the Safety and Efficacy of JHM03 in Adult Patients With Upper Limb Spasticity

JHM BioPharma (Tonghua) Co. , Ltd.

Status and phase: Completed; Phase 2; Phase 1

Conditions: Upper Limb Spasticity

Treatments: Drug: Sequence 1; Drug: Sequence 4; Drug: Sequence 2; Drug: Sequence 5; Drug: Sequence 3

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT06584240

JHM03-CT102

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84 participants in 5 patient groups, including a placebo group

Experimental Group 1

Experimental group

Description:

Participants will receive one cycle of JHM03 in the selected overactive upper limb muscles

Treatment:

Drug: Sequence 1

Experimental Group 2

Experimental group

Description:

Participants will receive one cycle of JHM03 in the selected overactive upper limb muscles

Treatment:

Drug: Sequence 2

Experimental Group 3

Experimental group

Description:

Participants will receive one cycle of JHM03 in the selected overactive upper limb muscles

Treatment:

Drug: Sequence 3

Experimental Group 4

Experimental group

Description:

Participants will receive one cycle of JHM03 in the selected overactive upper limb muscles

Treatment:

Drug: Sequence 4

Placebo Group

Placebo Comparator group

Description:

Participants will receive one cycle of Placebo in the selected overactive upper limb muscles

Treatment:

Drug: Sequence 5