A Single Center, Phase I Clinical Trial to Evaluate the Safety of LIZTOX Inj in the Treatment of Post Stroke Upper Limb Spasticity

Phase 1

• Conditions: Post Stroke Upper Limb Spasticity
• Interventions: Biological: HU-014 Inj

• Registration Number: NCT04415346
• Lead Sponsor: Huons Co., Ltd.

Brief Summary

* Investigational Product: LIZTOX inj 100unit(HU-014)

* Title : A Single Center, Phase I Clinical Trial to Evaluate the Safety of LIZTOX Inj in the Treatment of Post Stroke Upper Limb Spasticity

* Sites and investigators : Asan Medical Center(Seoul), Min-ho Chun, M.D, Ph.D

* Objective : To evaluate the safety of LIZTOX inj in the treatment of Post Stroke Upper Limb Spasticity

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-06
• Status Verified: 2020-05
• Study First Submitted: 2020-05-31
• Study First Submitted QC: 2020-05-31
• Last Update Submitted: 2020-05-31
• Primary Completion: 2020-06
• Study First Posted: 2020-06-04
• Last Update Posted: 2020-06-04
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• A subject who is diagnosed with Stroke at least six weeks prior to Screening.
• A subject who has Modified ashworth scale(MAS) score which Wrist Flexor is ≥ 2 and Flexor or Finger Flexor is ≥ 1.
• A subject with a Disability assessment scale(DAS)of at least ≥ 2 in one of the categories of hand hygiene, clothing, upper extremity, or pain for evaluation.

Exclusion Criteria

• A subject who has medical history following. (Allergy, Chemodenervation(within 6 months), Tendon lengthening(within 6 months), Intrathecal baclofen.Aspiration pneumonia, etc.)
• A subject who has history of any diseases following. (neuromuscular junction disorder, NMJ, myasthemia gravis, MG, Lambert-Eaton myasthenic syndrome, amyotrophic lateral sclerosis, ALS, Skin disease, Dysphagia, etc.)
• From screening, Subject who get a plastic Surgery including fascioplasty, Prosthesis implantation within 6 Weeks
• Subject who takes a medication including skeletal muscle relaxants, Aminoglycoside, lincomycin, anticholinergic drug, benzodiazepine, benzamide etc.
• A subject who tend to bleed or are taking anti-coagulant drugs.
• A sugject who is undergoing rehabilitation(physical therapy, occupational therapy, exercise therapy) or Splinting in the area where medication for clinical trials is scheduled to be administered.
• A sugject who has muscle atrophy, fixed joint/muscle contracture in the area where medication for clinical trials is scheduled to be administered.
• Any condition that, in the view of the investigator, would interfere with study participation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HU-014 Inj(Phase 1	HU-014 Inj	HU-014 Inj was given an injection to 5 Upper limb muscle(Total 360U/, IM)

Primary Outcome Measures

Name	Time	Method
MAS score improvement at Wrist Flexor, Elbow Flexor, Finger Flexor	Week 4, 8, 12 from baseline visit(=Investigational product Injection)	The rate of change in muscle tension measured by MAS

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Songpa-gu, Korea, Republic of