Status:
COMPLETED
Pharmacodynamic and Safety of MT10107(Botulinum Type A Neurotoxin) in Comparison to BOTOX®
Lead Sponsor:
Medy-Tox
Conditions:
Healthy Volunteers
Eligibility:
MALE
20-65 years
Phase:
PHASE1
Brief 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 ...
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 Bot...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03796351
Start Date
September 1 2012
End Date
January 1 2013
Last Update
August 26 2020
Active Locations (1)
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1
The Catholic University of Korea, St. Paul's Hospital
Seoul, South Korea