None listed
Conditions
Interventions
Drug : 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 stud
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 r
Sponsors
Medytox
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Healthy male adults aged between 20 and 65 years 2. 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. 3. Have no clinically significant medical conditions. 4. Able to provide written informed consent. 5. Able to attend all assessment visits.
Exclusion criteria
Exclusion criteria: 1. Subjects who have previously been treated in 3 month with botulinum toxin type A. 2. Subjects who had childhood botulism. 3. Subjects who have a pacemaker or other heart device. 4. Subjects who have had previous myotomy or denervation surgery in the muscle of interest (e.g., peripheral denervation and/or spinal cord stimulation). 5. Subjects with peripheral neuropathy and/or an accessary peroneal nerve. 6. Participation in any research study involving drug administration and/or significant blood loss. 7. Subjects with laboratory (haematology and biochemistry) or urinalysis results out of the normal range and considered to be of clinical significance by the investigator. 8. Subjects with a history of alcohol abuse and/or drug habituation. 9. Subjects who take regular medication. 10. Subjects with allergy or hypersensitivity to the investigational products or their components 11. Subjects who have been given any of the following drugs within previous 4 weeks at screening: Muscle relaxants, Benzodiazepines 12. Subjects who do not agree to use barrier method contraception (i.e. condoms) for the duration of the study. 13. 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. 14.Patients who are not eligible for this study at the discretion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage reduction in CMAP M-wave amplitude in EDB muscle compared with the individual mean baseline value. | — |
Secondary
| Measure | Time frame |
|---|---|
| Local aderse events of both lower exrtemity;The potential diffusion effect on the adjacent muscles (AH and ADQ) as measured by surface EMG. ;The percentage reduction in CMAP M-wave amplitude in EDB muscle compared with the individual mean baseline value.;Adverse events (AEs), vital signs, clinical laboratory changes (haematology, blood chemistry and urinalysis) and ECG monitoring outcomes. | — |
Countries
Korea, Republic of
Contacts
Public ContactChung Eun
The Catholic University of Korea, St. Paul's Hospital
Outcome results
None listed