NCT07292025

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Jetema Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Upper Limb Spasticity Post-Stroke

Interventions

Type	Name	Description
DRUG	JTM201 in normal saline	Max 360 U of Test drug IM
DRUG	BOTOX 100U in normal saline	Max 360 U of BOTOX IM

Timeline

• Start date: 2023-06-29
• Primary completion: 2024-04-22
• Completion: 2024-09-04
• First posted: 2025-12-18
• Last updated: 2025-12-18

Locations

1 site across 1 country: South Korea