Safety, Tolerability and Pharmacodynamics of SXN102308

• Research type

  Research Study

• Full title

  A phase I, double-blind, randomised, placebo-controlled study in healthy male subjects to assess the safety, tolerability and pharmacodynamics of intramuscular single ascending doses of SXN102308 (Part A) and assess the pharmacodynamics of two intramuscular single doses of abobotulinum toxin A (Dysport®) (Part B)

• IRAS ID

  213957

• Contact name

  Peter Dewland

• Contact email

  peterdewland@macplc.com

• Sponsor organisation

  Aepodia France S.A.R.L.

• Eudract number

  2016-002609-20

• Duration of Study in the UK

  Publication of this data is currently deferred.

• Research summary

  This is a study to assess the safety and tolerability of a new type of Botulinum neurotoxin (BoNT) called SXN102308, to assess how different doses of the compound affect the body following a single injection into the Extensor Digitorum Brevis (EDB) muscle in the foot of healthy male subjects aged 18 to 55, and to assess the pharmacodynamics of two intramuscular single doses of abobotulinum toxin A (Dysport®) (Part B) a marketed botulinum toxin A licensed in the UK for removing facial lines and also for treatment of muscle spasms and spasticity or tightness.

• REC name

  Wales REC 1

• REC reference

  16/WA/0300

• Date of REC Opinion

  20 Oct 2016

• REC opinion

  Further Information Favourable Opinion