Healthy VolunteersPhase 1NCT03796351
Pharmacodynamic and Safety of MT10107(Botulinum Type A Neurotoxin) in Comparison to BOTOX®
A Phase 1 study testing MT10107 and Botox in people with Healthy Volunteers, run by Medy-Tox at 1 site in South Korea.
Trial summary
This study design is a randomized, double-blind, intra-individual controlled, single-center, phase 1 healthy volunteer study. Subjects who voluntarily signed the informed consent and are judged to be eligible for this study will be intramuscularly injected with the study drug or the comparator at a randomized unit(2U… Read more about this study
- Who is it for?
- Ages 20 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- MT10107 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
- Sep 2012to Jan 2013
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male adults aged between 20 and 65 years
- Subjects with CMAP M-wave amplitude of the EDM muscle of ≥ 4.0 mV, CMAP M-wave amplitude of the AH muscle of ≥ 5.0 mV, and CMAP M-wave amplitude of the ADQ muscle of ≥ 5.0 mV.
- Have no clinically significant medical conditions.
- Able to provide written informed consent.
- Able to attend all assessment visits.
Who cannot join
- Subjects who have previously been treated in 3 month with botulinum toxin type A.
- Subjects who had childhood botulism.
- Subjects who have a pacemaker or other heart device.
- Subjects who have had previous myotomy or denervation surgery in the muscle of interest (e.g., peripheral denervation and/or spinal cord stimulation).
- Subjects with peripheral neuropathy and/or an accessary peroneal nerve.
- Participation in any research study involving drug administration and/or significant blood loss.
Show all 14Show fewer
- Subjects with laboratory (haematology and biochemistry) or urinalysis results out of the normal range and considered to be of clinical significance by the investigator.
- Subjects with a history of alcohol abuse and/or drug habituation.
- Subjects who take regular medication.
- Subjects with allergy or hypersensitivity to the investigational products or their components
- Subjects who have been given any of the following drugs within previous 4 weeks at screening: Muscle relaxants, Benzodiazepines
- Subjects who do not agree to use barrier method contraception (i.e. condoms) for the duration of the study.
- Subjects who participate in regular physical activity/sport, which requires high load and intensity to the foot and cannot be stopped for the duration of the study.
- Patients who are not eligible for this study at the discretion of the investigator
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: A Randomized, Double-blind, Intra-Individual Controlled, Single-Center, Phase 1 Healthy Volunteer Study
This study design is a randomized, double-blind, intra-individual controlled, single-center, phase 1 healthy volunteer study. Subjects who voluntarily signed the informed consent and are judged to be eligible for this study will be intramuscularly injected with the study drug or the comparator at a randomized unit(2U, 5U, 10U, 20U, 30U) in each site of the Extensor digirotum brevis. Thereafter, follow-up visits will be made 14 days, 30days, 60days, 90days and pharmacodynamic and safety assessments will be conducted for total 90days.
Read the detailed description
This is a randomised, double-blind, intra-individual controlled, dose escalation study to assess the safety, tolerability and preliminary effectiveness of a single dose of MT10107 in comparison to Botox®50U (BOTOX® is a registered trademark owned by Allergan). This is the first-in-human study for MT10107, and will be performed in healthy volunteers.
Subjects will be administered a single equivalent dose of MT10107 and Botox®50U by intramuscular injection to the EDB muscles of contralateral feet. Five cohorts of eligible subjects will be studied; Group A (2 U dose), Group B (5 U dose), Group C (10 U dose), Group D (20 U dose) and Group E (30 U dose).
The foot in which each drug is to be administered (i.e. left or right) will be assigned in a randomized manner.
- Conditions
- Healthy Volunteers
- Being tested
- MT10107, Botox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT10107Drug
Also called Coretox
Subjects will be administered a single equivalent dose of MT10107 and Botox® by intramuscular injection to the EDB muscles of contralateral feet. Five cohorts of eligible subjects will be studied; Group A (2 U dose), Group B (5 U dose), Group C (10 U dose), Group D (20 U dose) and Group E (30 U dose).
The foot in which each drug is to be administered (i.e. left or right) will be assigned in a randomized manner.
BotoxDrug
Subjects will be administered a single equivalent dose of MT10107 and Botox® by intramuscular injection to the EDB muscles of contralateral feet. Five cohorts of eligible subjects will be studied; Group A (2 U dose), Group B (5 U dose), Group C (10 U dose), Group D (20 U dose) and Group E (30 U dose).
The foot in which each drug is to be administered (i.e. left or right) will be assigned in a randomized manner.
| Study group | Role | What they receive |
|---|---|---|
| MT10107(botulinum toxin type A) | Experimental | Subjects will be administered a single equivalent dose of MT10107 by intramuscular injection to the EDB muscles of contralateral feet in five treatment group. Receives: Drug: MT10107 |
| BOTOX® 50U(botulinum toxin type A) | Active comparator | Subjects will be administered a single equivalent dose of BOTOX® 50U by intramuscular injection to the EDB muscles of contralateral feet in five treatment group. Receives: Drug: Botox |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage change in CMAP M-wave amplitude in EDB muscle compared with the individual mean baseline value.
percentage change of CMAP(Compound Muscle Action Potential) amplitude of the EDB(Extensor Digitorum Brevis) muscle from baseline
Measured: 30 days after the injection
Secondary outcomes (2)
The potential diffusion effect on the adjacent muscles (AH and ADQ) as measured by surface EMG.
percentage change of CMAP(Compound Muscle Action Potential) amplitude of the adjacent muscles (AH and ADQ) from baseline
Measured: 14, 30 and 90 days after the injection
The percentage change in CMAP M-wave amplitude in EDB muscle compared with the individual mean baseline value.
percentage change of CMAP(Compound Muscle Action Potential) amplitude of the EDB(Extensor Digitorum Brevis) muscle from baseline
Measured: 14 and 90 days after the injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study startSep 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Screening
- 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
- Investigators
- MyungEun Chung, Principal investigator, Catholic University of Korea Saint Paul's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03796351
- Sponsor's protocol ID
- MT_PRT_EDB01
- Status last verified
- Aug 2020
- First submitted
- 26 Nov 2015
- Last updated
- 26 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Intra-Individual Controlled, Single-Center, Phase 1 Healthy Volunteer Study
- ClinicalTrials.gov ID
- NCT03796351
- Acronym / sponsor ID
- MT_PRT_EDB01
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Medy-ToxIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 8 Jan 2019 (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 design is a randomized, double-blind, intra-individual controlled, single-center, phase 1 healthy volunteer study. Subjects who voluntarily signed the informed consent and are judged to be eligible for this study will be intramuscularly injected with the study drug or the comparator at a randomized unit(2U, 5U, 10U, 20U, 30U) in each site of the Extensor digirotum brevis. Thereafter, follow-up visits will be made 14 days, 30days, 60days, 90days and pharmacodynamic and safety assessments will be conducted for total 90days.
Detailed description
This is a randomised, double-blind, intra-individual controlled, dose escalation study to assess the safety, tolerability and preliminary effectiveness of a single dose of MT10107 in comparison to Botox®50U (BOTOX® is a registered trademark owned by Allergan). This is the first-in-human study for MT10107, and will be performed in healthy volunteers.
Subjects will be administered a single equivalent dose of MT10107 and Botox®50U by intramuscular injection to the EDB muscles of contralateral feet. Five cohorts of eligible subjects will be studied; Group A (2 U dose), Group B (5 U dose), Group C (10 U dose), Group D (20 U dose) and Group E (30 U dose).
The foot in which each drug is to be administered (i.e. left or right) will be assigned in a randomized manner.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MT10107(botulinum toxin type A) | Experimental | Drug: MT10107Subjects will be administered a single equivalent dose of MT10107 by intramuscular injection to the EDB muscles of contralateral feet in five treatment group. |
| BOTOX® 50U(botulinum toxin type A) | Active comparator | Drug: BotoxSubjects will be administered a single equivalent dose of BOTOX® 50U by intramuscular injection to the EDB muscles of contralateral feet in five treatment group. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy male adults aged between 20 and 65 years
- Subjects with CMAP M-wave amplitude of the EDM muscle of ≥ 4.0 mV, CMAP M-wave amplitude of the AH muscle of ≥ 5.0 mV, and CMAP M-wave amplitude of the ADQ muscle of ≥ 5.0 mV.
- Have no clinically significant medical conditions.
- Able to provide written informed consent.
- Able to attend all assessment visits.
Key exclusion criteria (14 listed)
- Subjects who have previously been treated in 3 month with botulinum toxin type A.
- Subjects who had childhood botulism.
- Subjects who have a pacemaker or other heart device.
- Subjects who have had previous myotomy or denervation surgery in the muscle of interest (e.g., peripheral denervation and/or spinal cord stimulation).
- Subjects with peripheral neuropathy and/or an accessary peroneal nerve.
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 |
|---|---|---|
| MT10107Also: CoretoxSubjects will be administered a single equivalent dose of MT10107 and Botox® by intramuscular injection to the EDB muscles of contralateral feet. Five cohorts of eligible subjects will be studied; Group A (2 U dose), Group B (5 U dose), Group C (10 U dose), Group D (20 U dose) and Group E (30 U dose). The foot in which each drug is to be administered (i.e. left or right) will be assigned in a randomized manner. | Drug | MT10107(botulinum toxin type A) |
| BotoxSubjects will be administered a single equivalent dose of MT10107 and Botox® by intramuscular injection to the EDB muscles of contralateral feet. Five cohorts of eligible subjects will be studied; Group A (2 U dose), Group B (5 U dose), Group C (10 U dose), Group D (20 U dose) and Group E (30 U dose). The foot in which each drug is to be administered (i.e. left or right) will be assigned in a randomized manner. | Drug | BOTOX® 50U(botulinum toxin type A) |
Primary outcome
The percentage change in CMAP M-wave amplitude in EDB muscle compared with the individual mean baseline value.
Time frame: 30 days after the injection
percentage change of CMAP(Compound Muscle Action Potential) amplitude of the EDB(Extensor Digitorum Brevis) muscle from baseline
2 secondary outcomes
The potential diffusion effect on the adjacent muscles (AH and ADQ) as measured by surface EMG.
Time frame: 14, 30 and 90 days after the injection
The percentage change in CMAP M-wave amplitude in EDB muscle compared with the individual mean baseline value.
Time frame: 14 and 90 days after the injection
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 26 Aug 2020.
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Screening Protocol
Pain
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.
MyungEun Chung principal investigator
Catholic University of Korea Saint Paul's Hospital
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 MT10107 and Botox in people with Healthy Volunteers, 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 5 inclusion and 14 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 26 Aug 2020. 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?
The percentage change in CMAP M-wave amplitude in EDB muscle compared with the individual mean baseline value. (time frame: 30 days after the injection). 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 26 Aug 2020.