Study to Assess the Efficacy, Safety and Tolerability of MT- 8554 in Subjects With Painful Diabetic Peripheral Neuropathy

A Phase IIa, Multi-Centre, Randomised, Double-Blind, Cross-Over, Placebo-Controlled Study to Assess the Efficacy, Safety and Tolerability of MT-8554 in Subjects With Painful Diabetic Peripheral Neuropathy Incorporating an Open Label Pilot Arm

A Study to Investigate the Safety, Tolerability and Efficacy of Multiple Doses of MT-8554 in Subjects with Painful Diabetic Peripheral Neuropathy

Inclusion Criteria:

• Male subjects and female subjects aged ≥18 years
• Subjects who have a history of pain at least 6 months and ≤7 years attributed to diabetic peripheral neuropathy
• A body mass index ranging from 18 to 45 kg/m2

Exclusion Criteria:

• Subjects who have participated in a clinical study of any IMP (other than placebo) within 12 weeks (from last administration) prior to screening or who are currently participation in another clinical study
• Unstable or uncontrolled diabetes
• Clinically significant 12-lead ECG abnormalities