drugset / Trial / NCT03796351
Pharmacodynamic and Safety of MT10107(Botulinum Type A Neurotoxin) in Comparison to BOTOX®
RandomizedParallel-groupQuadruple-blindScreening
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.
Timeline
- Start
- 2012-09
- Primary completion
- 2013-01
- Completion
- 2013-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Botulinum toxin type A | Protein / enzyme biologic | 2 iu | Intramuscular |
| Comparator | Botulinum toxin type A | Protein / enzyme biologic | 5 iu | Intramuscular |
| Comparator | Botulinum toxin type A | Protein / enzyme biologic | 10 iu | Intramuscular |
| Comparator | Botulinum toxin type A | Protein / enzyme biologic | 20 iu | Intramuscular |
| Comparator | Botulinum toxin type A | Protein / enzyme biologic | 30 iu | Intramuscular |
| Subject | CORETOX® | Unknown | 2 iu | Intramuscular |
| Subject | CORETOX® | Unknown | 5 iu | Intramuscular |
| Subject | CORETOX® | Unknown | 10 iu | Intramuscular |
| Subject | CORETOX® | Unknown | 20 iu | Intramuscular |
| Subject | CORETOX® | Unknown | 30 iu | Intramuscular |
Indications
No indication recorded.