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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 3 Doses of MOTREM (Nangibotide) in Patients With Septic Shock

NCT03158948 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-10-08

Study results available
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Summary

This is a randomised, double-blind, two-stage, placebo controlled study. It is designed to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of 3 doses of nangibotide versus placebo in adult patients with septic shock.

Conditions

  • Shock, Septic

Interventions

DRUG

Nangibotide 0.3 mg/kg

Formulated LR12 peptide

DRUG

Placebo

placebo

DRUG

Nangibotide 1 mg/kg

Formulated LR12 peptide

DRUG

Nangibotide 3 mg/kg

Formulated LR12 peptide

Sponsors & Collaborators

  • Inotrem

    lead INDUSTRY

Principal Investigators

  • Bruno François, MD · Inserm 1435 Clinical Investigational Center, Limoges, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-03
Primary Completion
2018-06-13
Completion
2018-06-13

Countries

  • Belgium
  • France
  • Netherlands
  • 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 NCT03158948 on ClinicalTrials.gov