Date: 2017-06-14
Type of
information: Completion of the trial
phase: 1
Announcement: completion of the trial
Company: Sanifit (Spain - Switzerland)
Product: SNF472 - hexasodium phytate
Action
mechanism:
Disease: calciphylaxis
Therapeutic
area: Rare diseases - Cardiovascular diseases
Country: UK
Trial
details:
Latest
news:
- • On June 17, 2014, Sanifit announced that the company has completed Phase I clinical trials in healthy volunteers with SNF472. This double-blind, randomized, single ascending dose study was performed in twenty healthy male volunteers. Single ascending doses of SNF472 were administered by a 4-hour infusion in a leap-frog design. Apart from standard safety parameters and pharmacokinetics, a biomarker of calcification was used to assess pharmacodynamics.
- The good safety profile, together with the excellent PK-PD profile of SNF472, which were found in this study, supports the continuation of the development program. The next step will be starting clinical studies in haemodialysis patients.
- • On April 1, 2014, Sanifit Laboratories received authorization from the MHRA and the ethics committee to initiate Phase I studies in London. These tests evaluate in healthy volunteers and dialysis patients, the safety, pharmacokinetics and efficacy of SNF472.
Is
general: Yes
