Pharmacodynamic and Safety of MT10107(Botulinum Type A Neurotoxin) in Comparison to BOTOX®

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.

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• 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