NCT03595189

Safety, Tolerability and Pharmacokinetic Profile of an Infusion of Cilastatin in Healthy Volunteers.

Dose Escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of an Infusion of Cilastatin in Healthy Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Spherium Biomed · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

The study is designed as 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 will involve 24 healthy male and female healthy subjects, divided in three study cohorts (8 subjects per cohort). The study is a dose escalating study, starting from 3 g of Cilastatin administered intravenously in 3 hours. Eight subjects will be randomized and assigned to either the study drug or placebo group for each study cohort in a 3:1 ratio (6 actives and 2 placebos). Randomization will also be gender balanced within each study cohort. The planned dose escalation scheme should not occur before participants in the previous dose level have been treated and safety profile of Cilastatin from those participants are assessed in accordande with the protocol.

Conditions

• Dose Finding Study

Interventions

Type	Name	Description
DRUG	Cilastatin	Dose escalation 3-hour single intravenous administration
DRUG	Placebo	3-hour single intravenous administration

Timeline

• Start date: 2018-06-19
• Primary completion: 2018-08-09
• Completion: 2018-08-09
• First posted: 2018-07-23
• Last updated: 2018-10-09

Locations

1 site across 1 country: Spain