Healthy Volunteer Study to Determine the Safety and Tolerability of MT10109 (Clostridium Botulinum Toxin Type A) in Comparison to Botox(Registered Trademark)

A Randomised, Double-Blind, Intra-Individual Controlled, Single-Center, Phase I Dose Escalation Healthy Volunteer Study to Determine the Safety and Tolerability of MT10109 (Clostridium Botulinum Toxin Type A) in Comparison to Botox(Registered Trademark)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000077965

Enrollment

Registered

2011-01-21

Start date

2011-01-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is designed to compare the safety and efficacy of the investigational drug MT10109, a new formulation of Clostridium Botulinum Toxin Type A compared to Botox (Registered trademark). Subjects will have a single injection of MT10109 injected into the Extensor Digitorum Brevis (EDB) muscle of one foot and an equivalent dosage of Botox injected into the other foot.

Interventions

MT10109: Clostridium Botulinum Toxin Type A. Subjects will be administered a single equivalent dose of MT10109 by intramuscular injection to the EDB muscle of either the left or right foot, the comparator will be administered to the other foot. Four cohorts of eligible subjects will be studied; Group A (2.5 U dose), Group B (5 U dose), Group C (10 U dose), and Group D (20 U dose). The foot in which the drug is to be administered (i.e. left or right) will be assigned in a randomized manner. Su

Study design

Allocation

Randomised controlled trial

Intervention model

Other

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

Male

Age

18 Years to 75 Years

Healthy volunteers

Yes

Inclusion criteria

1. Subjects with compound muscle action potential (CMAP) M-wave amplitude of the extensor digitorum brevis muscle of = 4.0 mV, CMAP M-wave amplitude of the Abductor hallicis muscle of = 5.0 mV, and CMAP M-wave amplitude of the Abductor digiti quinti muscle of = 5.0 mV. 2. Subjects with a normal muscle power of the toes (score = 5) on the Medical Research Council (MRC) scale. 3. Have no clinically significant medical or neurological conditions. 5. Able to attend all assessment visits.

Exclusion criteria

1. Subjects who have previously been treated with botulinum toxin type A. 2. Subjects who had childhood botulism. 3. Subjects who have had previous myotomy or denervation surgery in the muscle of interest (e.g., peripheral denervation and/or spinal cord stimulation). 4. Subjects who have a pacemaker or other heart device. 5. Subjects with peripheral neuropathy and/or an accessary peroneal nerve.

Outcome results