Moderate to Severe Glabellar LinesPhase 1/2NCT06199336
A Phase I/II, Randomized, Double-blind, Placebo, and Active Controlled Clinical Study to Evaluate the Safety, Tolerability, Immunogenicity, and Preliminary Efficacy of JHM03 in Subjects With Moderate to Severe Glabellar Lines
A Phase 1/2 study testing JHM03 and BOTOX® in people with Moderate to Severe Glabellar Lines, run by JHM BioPharma (Tonghua) Co. , Ltd. at 1 site in China.
Trial summary
This is a phase 1/2, multicenter, randomized, double-blind, active-controlled and placebo-controlled study to evaluate safety, immunogenicity and efficacy of JHM03 for the treatment of moderate to severe glabellar lines in male and female subjects of Chinese origin. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Moderate to Severe Glabellar Lines
- What is being tested?
- JHM03 and BOTOX®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 1 siteChina
- Study dates
- 19 Jan 2024to 9 Sep 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects between 18 and 65 years of age.
- Moderate to severe glabellar lines at maximum frown at baseline.
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.
- Use of medications that affect neuromuscular transmission within 4 weeks prior to screening, such as muscle relaxant,aminoglycoside antibiotics,anticholinergic drugs,benzodiazepines,etc.
- Suffering from any neurological disorders that increase the risk of exposure to botulinum toxin type A, including peripheral motor nerve diseases (such as amyotrophic lateral sclerosis and motor neuropathy), as well as neuromuscular junction diseases (such as Lambert-Eaton syndrome and myasthenia gravis).
- Known allergy or hypersensitivity to any component of the study products.
- Use of any non-steroid anti-inflammatory drug or anticoagulant within 1 week prior to study treatment.
- History of alcohol or drug abuse.
Trial locations and contacts
1 site in 1 country.
About this study
This is a phase 1/2, multicenter, randomized, double-blind, active-controlled and placebo-controlled study to evaluate safety, immunogenicity and efficacy of JHM03 for the treatment of moderate to severe glabellar lines in male and female subjects of Chinese origin. The purpose of this study was to observe efficacy and safety of JHM03 compared with placebo and BOTOX® in moderate to severe glabellar lines.
- Conditions
- Moderate to Severe Glabellar Lines
- Being tested
- JHM03, BOTOX®, Placebo
- Keywords
- Recombinant Botulinum Toxin Type A, Glabellar Lines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JHM03Biological
Single treatment, intramuscularly injected into five sites. The total injection volume is 0.5 ml,0.1 ml per site.
BOTOX®Biological
Single treatment,intramuscularly injected into five sites.The total injection volume is 0.5 ml,0.1 ml per site.
PlaceboBiological
Single treatment,intramuscularly injected into five sites.The total injection volume is 0.5 ml,0.1 ml per site.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Single injection with JHM03 in glabellar lines Receives: Biological: JHM03 |
| Active-Controlled Group | Active comparator | Single injection with BOTOX® in glabellar lines Receives: Biological: BOTOX® |
| Placebo-Controlled Group | Placebo comparator | Single injection with Placebo in glabellar lines. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase1
The incidence rate of adverse events and severe adverse events within 28 days after injection;
Measured: Within 28 days
Phase2
Percentage of Subjects as Responders in the Investigator's live assessment (Using 4-point Photographic Scale) and the subject's self assessment of Glabellar Lines at Maximum Frown.
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 posted10 Jan 2024
- Study start19 Jan 2024
- Primary completion9 Sep 2024
- Study completion9 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Glabellar LinesStudies 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
- Placebo and active controlled
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 190 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
- NCT06199336
- Sponsor's protocol ID
- JHM03-CT101
- Status last verified
- Apr 2024
- First submitted
- 29 Dec 2023
- Last updated
- 2 Apr 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 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Randomized, Double-blind, Placebo, and Active Controlled Clinical Study to Evaluate the Safety, Tolerability, Immunogenicity, and Preliminary Efficacy of JHM03 in Subjects With Moderate to Severe Glabellar Lines
- ClinicalTrials.gov ID
- NCT06199336
- Acronym / sponsor ID
- JHM03-CT101
- Conditions
- Moderate to Severe Glabellar Lines
- Keywords
- Recombinant Botulinum Toxin Type A, Glabellar Lines
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- JHM BioPharma (Tonghua) Co. , Ltd.Research network
- Study start
- 19 Jan 2024 (actual)
- Primary completion
- 9 Sep 2024 (actual)
- Study completion
- 9 Sep 2024 (actual)
- First posted
- 10 Jan 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 1/2, multicenter, randomized, double-blind, active-controlled and placebo-controlled study to evaluate safety, immunogenicity and efficacy of JHM03 for the treatment of moderate to severe glabellar lines in male and female subjects of Chinese origin. The purpose of this study was to observe efficacy and safety of JHM03 compared with placebo and BOTOX® in moderate to severe glabellar lines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Placebo and active controlled
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Biological: JHM03Single injection with JHM03 in glabellar lines |
| Active-Controlled Group | Active comparator | Biological: BOTOX®Single injection with BOTOX® in glabellar lines |
| Placebo-Controlled Group | Placebo comparator | Biological: PlaceboSingle injection with Placebo in glabellar lines. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female subjects between 18 and 65 years of age.
- Moderate to severe glabellar lines at maximum frown at baseline.
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.
- Use of medications that affect neuromuscular transmission within 4 weeks prior to screening, such as muscle relaxant,aminoglycoside antibiotics,anticholinergic drugs,benzodiazepines,etc.
- Suffering from any neurological disorders that increase the risk of exposure to botulinum toxin type A, including peripheral motor nerve diseases (such as amyotrophic lateral sclerosis and motor neuropathy), as well as neuromuscular junction diseases (such as Lambert-Eaton syndrome and myasthenia gravis).
- Known allergy or hypersensitivity to any component of the study products.
- Use of any non-steroid anti-inflammatory drug or anticoagulant within 1 week prior to study treatment.
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 |
|---|---|---|
| JHM03Single treatment, intramuscularly injected into five sites. The total injection volume is 0.5 ml,0.1 ml per site. | Biological | Treatment Group |
| BOTOX®Single treatment,intramuscularly injected into five sites.The total injection volume is 0.5 ml,0.1 ml per site. | Biological | Active-Controlled Group |
| PlaceboSingle treatment,intramuscularly injected into five sites.The total injection volume is 0.5 ml,0.1 ml per site. | Biological | Placebo-Controlled Group |
Primary outcome
Phase1
Time frame: Within 28 days
The incidence rate of adverse events and severe adverse events within 28 days after injection;
Phase2
Time frame: within 4 weeks
Percentage of Subjects as Responders in the Investigator's live assessment (Using 4-point Photographic Scale) and the subject's self assessment of Glabellar Lines at Maximum Frown.
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 Apr 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.
1 site 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 JHM03 and BOTOX® in people with Moderate to Severe Glabellar Lines, run by JHM BioPharma (Tonghua) Co. , Ltd. at 1 site 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 2 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 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Phase1 (time frame: Within 28 days). 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 Apr 2025.