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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06584240

Enrollment

Registered

2024-09-04

Start date

2024-09-14

Completion date

2025-07-23

Last updated

2025-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper Limb Spasticity

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.

Interventions

DRUGSequence 3

Single treatment, intramuscularly injected. The total injection 350-400U.

DRUGSequence 1

Single treatment, intramuscularly injected. The total injection 100-150U.

DRUGSequence 2

Single treatment, intramuscularly injected. The total injection 200-250U.

DRUGSequence 4

Single treatment, intramuscularly injected. The total injection ≤400U.

DRUGSequence 5

Single treatment, intramuscularly injected.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Double-blinded

Intervention model description

JHM03 and Placebo

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
The incidence rate of adverse events and severe adverse events	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	Within 4 weeks	Change from baseline at week 4 for primary targeted muscle group on the MAS(Modified Ashworth Scale).

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026