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NCT Number: NCT06584240

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

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.

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Key information

Conditions

Upper Limb Spasticity

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Beijing Tsinghua Changgung Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sequence 1

Drug

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

Sequence 2

Drug

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

Sequence 3

Drug

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

Sequence 4

Drug

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

Sequence 5

Drug

Single treatment, intramuscularly injected.

Primary outcomes

  1. The incidence rate of adverse events and severe adverse events

    Time frame: Within 12 weeks

    The incidence rate of adverse events and severe adverse events within 12 weeks after injection;

  2. Change from baseline at week 4 for primary targeted muscle group on the MAS

    Time frame: Within 4 weeks

    Change from baseline at week 4 for primary targeted muscle group on the MAS(Modified Ashworth Scale).

Sponsors and collaborators

Lead sponsor

JHM BioPharma (Tonghua) Co. , Ltd.

Network

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 4, 2024
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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