Pharmacodynamic and Safety of MBA-P01 in Healthy Male Volunteers

Medytox

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: MBA-P01; Drug: BOTOX

Study type: Interventional

Funder types: Industry

Identifiers

NCT03547141

MT14-KR18EDB102

Details and patient eligibility

About

To determine the pharmacodynamic and safety of MBA-P01 in Healthy Male Volunteers

Enrollment: 28 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male adults aged between 20 and 45 years

Exclusion criteria

• Subjects not appropriate for participating in this study according to the investigator's opinion

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 4 patient groups

botulinum toxin 1U

Experimental group

Treatment:

Drug: MBA-P01

Drug: BOTOX

botulinum toxin 5U

Experimental group

Treatment:

Drug: MBA-P01

Drug: BOTOX

botulinum toxin 15U

Experimental group

Treatment:

Drug: MBA-P01

Drug: BOTOX

botulinum toxin 30U

Experimental group

Treatment:

Drug: MBA-P01

Drug: BOTOX