Phase 1 Trial of JTM201 in Subjects With Post-stroke Upper Limb Spasticity

A Randomized, Double-blind, Active-controlled, Multicenter, Phase 1 Trial to Investigate the Safety and Efficacy of JTM201 in Subjects With Post-stroke Upper Limb Spasticity

Phase 1 trial to evaluate the safety and efficacy of JTM201 compared with 'Botox® Inj.' in subjects with post-stroke upper limb spasticity

Inclusion Criteria:

• Subjects (or legal representatives) who voluntarily decided the participation of the study and provide written informed consent
• Subjects ≥ 19 years of age, inclusive
• Subjects who was diagnosed stroke at least 6 months prior to screening
• Subjects with MAS score with the wrist flexor score ≥2 and at least one of the elbow flexor or finger flexor score ≥1
• Subjects with a Disability Assessment Scale (DAS) score ≥2 in at least one functional domain, hygiene, dressing, limb position, or pain, selected as the primary treatment goal
• Female subjects who are non-childbearing potential, or childbearing* subjects who are not pregnant, or breastfeeding, a negative serum pregnancy result during screening, and women and men of childbearing potential who agree to use medically acceptable contraceptive methods** or to be sexual abstinence during the study period

Exclusion Criteria:

• Any medical condition that may affect neuromuscular function (eg, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis)
• Subjects with dysphagia that, in the judgment of the investigator, may interfere with study participation
• Subjects with fixed joint/muscle contracture* at the planned injection sites
• Subjects with severe muscle atrophy at the planned injection sites
• Subjects with skin abnormalities such as infection, skin disease, or scar at the planned injection sites
• History of acute deterioration in pulmonary function within 3 months prior to screening [including but not limited to hospitalization due to asthma or COPD exacerbation, or pneumonia]
• History of chemodenervation using phenol or alcohol, or surgery at the planned injection site within 24 weeks prior to screening, or scheduled for treatment or surgical intervention during the study
• History of tendon lengthening of the study limb within 24 weeks prior to screening, or scheduled surgical intervention at the planned injection site during the study
• Previous treatment with botulinum toxin of any serotype in any area within 24 weeks prior to screening
• Subjects with ongoing treatment with intrathecal Baclofen
• Subjects who require the administration of concomitant medications or implementation of concomitant therapies during the study period