Clinical Trial: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 3 Doses of MOTREM in Patients With Septic Shock

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 3 Doses of MOTREM in Patients With Septic Shock. A Randomised, Double-blind, Two-Stage, Placebo Controlled S

Brief 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 MOTREM versus placebo in adult patients with septic shock.

Detailed Summary:
Sponsor: Inotrem

Current Primary Outcome:

• Vital signs [ Time Frame: 28 days ]
  systolic (SBP) and diastolic (DBP) blood pressure, heart rate, and body temperature (tympanic)
• ECG [ Time Frame: 28 days ]
  12-lead ECG
• Number of patients with clinically relevant abnormal laboratory values [ Time Frame: 28 days ]
  Laboratory tests related to hematology, biochemistry and coagulation
• Presence of anti-LR12 antibodies [ Time Frame: 28 days ]
  Number of patients with anti-LR12 anti drug antibodies
• Adverse events [ Time Frame: 28 days ]
  Number of patients with adverse events

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Inotrem

Dates:
Date Received: May 16, 2017
Date Started: May 2017
Date Completion: August 2018
Last Updated: May 17, 2017
Last Verified: May 2017