HealthyPhase 1NCT03317717
Pharmacodynamic and Safety of MEDITOXIN® in Healthy Male Volunteers
A Phase 1 study testing Meditoxin and Botox in people with Healthy, run by Medy-Tox at 1 site in South Korea.
Trial summary
This study will determine the pharmacodynamic and safety of MEDITOXIN® in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Meditoxin and Botox
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Oct 2017to 30 Jan 2018
- Phase
- Phase 1
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male adults aged between 20 and 45
- Satisfying baseline nerve conduction criteria in below at screening visit CMAP M-wave amplitude of EDB ≥ 4.0mV CMAP M-wave amplitude of AH ≥ 5.0mV CMAP M-wave amplitude of ADQ ≥ 5.0mV
Who cannot join
- Have history of childhood botulism
- Have a pacemaker or any other heart device
- Have peripheral neuropathy or accessary peroneal nerve
- Have history of lower limb myotomy or denervation surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic University of Korea, St. Paul's Hospital
Seoul
About this study
Official title: Phase 1 Study to Determine the Pharmacodynamic and Safety of MEDITOXIN®(Clostridium Botulinum Toxin Type A) in Healthy Male Volunteers
This study will determine the pharmacodynamic and safety of MEDITOXIN® in healthy male volunteers.
- Conditions
- Healthy
- Being tested
- Meditoxin, Botox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeditoxinDrug
injection of MEDITOXIN into EDB muscle of one foot and BOTOX into the same muscle of contralateral foot in equal doses
BotoxDrug
injection of MEDITOXIN into EDB muscle of one foot and BOTOX into the same muscle of contralateral foot in equal doses
| Study group | Role | What they receive |
|---|---|---|
| botulinum toxin 2U | Experimental | Not described Receives: Drug: Meditoxin; Drug: Botox |
| botulinum toxin 5U | Experimental | Not described Receives: Drug: Meditoxin; Drug: Botox |
| botulinum toxin 10U | Experimental | Not described Receives: Drug: Meditoxin; Drug: Botox |
| botulinum toxin 20U | Experimental | Not described Receives: Drug: Meditoxin; Drug: Botox |
| botulinum toxin 30U | Experimental | Not described Receives: Drug: Meditoxin; Drug: Botox |
What is being measured
The primary outcome is the main question the study is designed to answer.
CMAP(Compound Muscle Action Potential) amplitude of the EDB(Extensor Digitorum Brevis) muscle
percentage reduction of CMAP(Compound Muscle Action Potential) amplitude of the EDB(Extensor Digitorum Brevis) muscle from baseline
Measured: day 14, 30, 60, 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start12 Oct 2017
- Primary completion30 Jan 2018
- Study completion30 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medy-Tox
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03317717
- Sponsor's protocol ID
- MT01-KR17EDB107
- Status last verified
- Mar 2019
- First submitted
- 18 Oct 2017
- Last updated
- 27 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study to Determine the Pharmacodynamic and Safety of MEDITOXIN®(Clostridium Botulinum Toxin Type A) in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT03317717
- Acronym / sponsor ID
- MT01-KR17EDB107
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Medy-ToxIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2017 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 23 Oct 2017 (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 study will determine the pharmacodynamic and safety of MEDITOXIN® in healthy male volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| botulinum toxin 2U | Experimental | Drug: Meditoxin, Drug: Botox |
| botulinum toxin 5U | Experimental | Drug: Meditoxin, Drug: Botox |
| botulinum toxin 10U | Experimental | Drug: Meditoxin, Drug: Botox |
| botulinum toxin 20U | Experimental | Drug: Meditoxin, Drug: Botox |
| botulinum toxin 30U | Experimental | Drug: Meditoxin, Drug: Botox |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male adults aged between 20 and 45
- Satisfying baseline nerve conduction criteria in below at screening visit CMAP M-wave amplitude of EDB ≥ 4.0mV CMAP M-wave amplitude of AH ≥ 5.0mV CMAP M-wave amplitude of ADQ ≥ 5.0mV
Key exclusion criteria (4 listed)
- Have history of childhood botulism
- Have a pacemaker or any other heart device
- Have peripheral neuropathy or accessary peroneal nerve
- Have history of lower limb myotomy or denervation surgery
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 |
|---|---|---|
| Meditoxininjection of MEDITOXIN into EDB muscle of one foot and BOTOX into the same muscle of contralateral foot in equal doses | Drug | botulinum toxin 10U, botulinum toxin 20U, botulinum toxin 2U, botulinum toxin 30U, botulinum toxin 5U |
| Botoxinjection of MEDITOXIN into EDB muscle of one foot and BOTOX into the same muscle of contralateral foot in equal doses | Drug | botulinum toxin 10U, botulinum toxin 20U, botulinum toxin 2U, botulinum toxin 30U, botulinum toxin 5U |
Primary outcome
CMAP(Compound Muscle Action Potential) amplitude of the EDB(Extensor Digitorum Brevis) muscle
Time frame: day 14, 30, 60, 90
percentage reduction of CMAP(Compound Muscle Action Potential) amplitude of the EDB(Extensor Digitorum Brevis) muscle from baseline
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 27 Mar 2019.
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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 study testing Meditoxin and Botox in people with Healthy, run by Medy-Tox at 1 site in South Korea.
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 4 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 27 Mar 2019. 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 South Korea. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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?
CMAP(Compound Muscle Action Potential) amplitude of the EDB(Extensor Digitorum Brevis) muscle (time frame: day 14, 30, 60, 90). 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 27 Mar 2019.