Trials / Completed
CompletedNCT06584240
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
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 84 (actual)
- Sponsor
- JHM BioPharma (Tonghua) Co. , Ltd. · Network
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2024-09-14
- Primary completion
- 2025-05-24
- Completion
- 2025-07-23
- First posted
- 2024-09-04
- Last updated
- 2025-09-02
Locations
20 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06584240. Inclusion in this directory is not an endorsement.