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

NCT06584240 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2025-09-02

No results posted yet for this study

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.

Conditions

  • Upper Limb Spasticity

Interventions

DRUG

Sequence 1

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

DRUG

Sequence 2

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

DRUG

Sequence 3

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

DRUG

Sequence 4

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

DRUG

Sequence 5

Single treatment, intramuscularly injected.

Sponsors & Collaborators

  • JHM BioPharma (Tonghua) Co. , Ltd.

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-14
Primary Completion
2025-05-24
Completion
2025-07-23

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06584240 on ClinicalTrials.gov