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

NCT03595189 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2018-10-09

No results posted yet for this study

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.

Conditions

  • Dose Finding Study

Interventions

DRUG

Cilastatin

Dose escalation 3-hour single intravenous administration

DRUG

Placebo

3-hour single intravenous administration

Sponsors & Collaborators

  • Hospital Universitario La Paz

    collaborator OTHER

  • Spherium Biomed

    lead INDUSTRY

Principal Investigators

  • Jesús Frías, MD · Hospital Universitario La Paz

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-19
Primary Completion
2018-08-09
Completion
2018-08-09

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03595189 on ClinicalTrials.gov