Upper Limb SpasticityPhase 1/2NCT06584240
A Clinical Study to Evaluate the Safety and Efficacy of JHM03 in Adult Patients With Upper Limb Spasticity
A Phase 1/2 study testing Sequence 1, Sequence 2 and Sequence 3 in people with Upper Limb Spasticity, run by JHM BioPharma (Tonghua) Co. , Ltd. at 20 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Upper Limb Spasticity
- What is being tested?
- Sequence 1, Sequence 2 and Sequence 3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 20 sitesChina
- Study dates
- 14 Sep 2024to 23 Jul 2025
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
China20 sites
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality
The Second Xiangya Hospital of Central South University
Changsha, Hunan
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Zhujiang Hospital, Southern Medical University
Guangzhou, Guangdong
Huai 'an Second People's Hospital
Huai'an, Jiangsu
The First Hospital of Lanzhou University
Lanzhou, Gansu
Luoyang Central Hospital
Luoyang, Henan
Jiangsu Province Hospital
Nanjing, Jiangsu
Pingxiang People's Hospital
Pingxiang, Jiangxi
Rizhao People's Hospital
Rizhao, Shandong
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 200040
Yangzhi Affiliated Rehabilitation Hospital of Tongji University
Shanghai, Shanghai Municipality
Shengjing Hospital affiliated to China Medical University
Shenyang, Liaoning
Huazhong University of Science and Technology Union Hospital
Shenzhen, Guangdong
The Second Hospital of Hebei Medical Hospital
Shijiazhuang, Hebei
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu
Renmin Hospital of Wuhan University
Wuhan, Hubei
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Yantai Mountain Hospital
Yantai, Shandong
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
About this study
Official 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
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
- Being tested
- Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequence 1Drug
Single treatment, intramuscularly injected. The total injection 100-150U.
Sequence 2Drug
Single treatment, intramuscularly injected. The total injection 200-250U.
Sequence 3Drug
Single treatment, intramuscularly injected. The total injection 350-400U.
Sequence 4Drug
Single treatment, intramuscularly injected. The total injection ≤400U.
Sequence 5Drug
Single treatment, intramuscularly injected.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group 1 | Experimental | Participants will receive one cycle of JHM03 in the selected overactive upper limb muscles Receives: Drug: Sequence 1 |
| Experimental Group 2 | Experimental | Participants will receive one cycle of JHM03 in the selected overactive upper limb muscles Receives: Drug: Sequence 2 |
| Experimental Group 3 | Experimental | Participants will receive one cycle of JHM03 in the selected overactive upper limb muscles Receives: Drug: Sequence 3 |
| Experimental Group 4 | Experimental | Participants will receive one cycle of JHM03 in the selected overactive upper limb muscles Receives: Drug: Sequence 4 |
| Placebo Group | Placebo comparator | Participants will receive one cycle of Placebo in the selected overactive upper limb muscles Receives: Drug: Sequence 5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence rate of adverse events and severe adverse events
The incidence rate of adverse events and severe adverse events within 12 weeks after injection;
Measured: Within 12 weeks
Change from baseline at week 4 for primary targeted muscle group on the MAS
Change from baseline at week 4 for primary targeted muscle group on the MAS(Modified Ashworth Scale).
Measured: Within 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start14 Sep 2024
- Primary completion24 May 2025
- Study completion23 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Limb SpasticityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- JHM03 and Placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- JHM BioPharma (Tonghua) Co. , Ltd.
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584240
- Sponsor's protocol ID
- JHM03-CT102
- Status last verified
- Aug 2025
- First submitted
- 2 Sep 2024
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No