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

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: Male

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, 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Medy-Tox
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; onabotulinumtoxinA

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:

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