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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06584240
- Acronym / sponsor ID
- JHM03-CT102
- Conditions
- Upper Limb Spasticity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- JHM BioPharma (Tonghua) Co. , Ltd.Research network
- Study start
- 14 Sep 2024 (actual)
- Primary completion
- 24 May 2025 (actual)
- Study completion
- 23 Jul 2025 (actual)
- First posted
- 4 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- JHM03 and Placebo
| Arm | Type | Receives |
|---|---|---|
| Experimental Group 1 | Experimental | Drug: Sequence 1Participants will receive one cycle of JHM03 in the selected overactive upper limb muscles |
| Experimental Group 2 | Experimental | Drug: Sequence 2Participants will receive one cycle of JHM03 in the selected overactive upper limb muscles |
| Experimental Group 3 | Experimental | Drug: Sequence 3Participants will receive one cycle of JHM03 in the selected overactive upper limb muscles |
| Experimental Group 4 | Experimental | Drug: Sequence 4Participants will receive one cycle of JHM03 in the selected overactive upper limb muscles |
| Placebo Group | Placebo comparator | Drug: Sequence 5Participants will receive one cycle of Placebo in the selected overactive upper limb muscles |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sequence 1Single treatment, intramuscularly injected. The total injection 100-150U. | Drug | Experimental Group 1 |
| Sequence 2Single treatment, intramuscularly injected. The total injection 200-250U. | Drug | Experimental Group 2 |
| Sequence 3Single treatment, intramuscularly injected. The total injection 350-400U. | Drug | Experimental Group 3 |
| Sequence 4Single treatment, intramuscularly injected. The total injection ≤400U. | Drug | Experimental Group 4 |
| Sequence 5Single treatment, intramuscularly injected. | Drug | Placebo Group |
Primary outcome
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;
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence rate of adverse events and severe adverse events (time frame: Within 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.