KCT0000541Completed未知
A Randomised, Double-Blind, Intra-Individual Controlled, Single-Center, Phase I Healthy Volunteer Study to Determine the Pharmacodynamic and Safety of MT10107 (Botulinum Type A Neurotoxin) in Comparison to BOTOX®.
Medytox0 sites25 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 25
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional Study
Eligibility Criteria
- Ages
- 20(Year) to 65(Year) (—)
- Sex
- Male
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
Investigators
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