Safety, Tolerability and Pharmacokinetic Profile of an Infusion of Cilastatin in Healthy Volunteers.
Status:
Completed
Trial end date:
2018-08-09
Target enrollment:
Participant gender:
Summary
This is a phase I, randomized, single-blind, parallel group, placebo-controlled,
multi-cohort, first-in-human dose escalation study of a single IV 3-hour administration of
Cilastatin as stand-alone in healthy male and female volunteers.
The study objectives are:
The evaluation of safety and tolerability of single intravenous doses of cilastatin in
healthy volunteers administered as a 3-hour infusion.
The evaluation of the pharmacokinetic characteristics of Cilastatin after a single 3-hour
infusion dose.
Phase:
Phase 1
Details
Lead Sponsor:
Spherium Biomed
Collaborators:
Hospital Universitario La Paz Hospital Universitario La Paz, Madrid