Safety, Tolerability and Pharmacokinetic Profiles of MOTREM (LR12) in Healthy Male Subjects

June 13, 2018 updated by: Inotrem

A Phase I, Randomised, Placebo Controlled Study to Assess the Safety, Tolerability and Pharmacokinetic Profiles of Ascending, Single, Intravenous Doses of MOTREM (LR12) in Healthy Male Subjects

This was a single center, randomized, placebo-controlled study with a sequential i.v. dose escalation cohorts design, to assess safety, tolerability and pharmacokinetics of MOTREM (nangibotide) in healthy volunteers

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • healthy male
  • ≥18 to ≤45 years old
  • Body mass index (BMI) between 18-30 kg/m² inclusive
  • Written informed consent to participate.

Main Exclusion Criteria:

  • Any clinically relevant acute or chronic diseases
  • Any history of drug or alcohol abuse
  • Any History of clinical significant disease as determined by medical history, physical examination or other evaluations.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo
Experimental: MOTREM 1
Drug: nangibotide
Continous i.v. infusion
Other Names:
  • LR12
  • MOTREM
Experimental: MOTREM 2
Drug: nangibotide
Continous i.v. infusion
Other Names:
  • LR12
  • MOTREM
Experimental: MOTREM 3
Drug: nangibotide
Continous i.v. infusion
Other Names:
  • LR12
  • MOTREM
Experimental: MOTREM 4
Drug: nangibotide
Continous i.v. infusion
Other Names:
  • LR12
  • MOTREM
Experimental: MOTREM 5
Drug: nangibotide
Continous i.v. infusion
Other Names:
  • LR12
  • MOTREM
Experimental: MOTREM 6
Drug: nangibotide
Continous i.v. infusion
Other Names:
  • LR12
  • MOTREM
Experimental: MOTREM 7
Drug: nangibotide
Continous i.v. infusion
Other Names:
  • LR12
  • MOTREM
Experimental: MOTREM 8
Drug: nangibotide
Continous i.v. infusion
Other Names:
  • LR12
  • MOTREM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability: Number of subjects with at least one adverse event
Time Frame: 28 days
Number of subjects with at least one adverse event
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics (Maximum Plasma Concentration)
Time Frame: 8 hours
Maximum Plasma Concentration [Cmax]
8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inotrem

Collaborators

Richmond Pharmacology Limited

Investigators

  • Study Director: Valérie Cuvier, Inotrem

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

August 25, 2016

Study Completion (Actual)

August 25, 2016

Study Registration Dates

First Submitted

February 27, 2018

First Submitted That Met QC Criteria

March 12, 2018

First Posted (Actual)

March 13, 2018

Study Record Updates

Last Update Posted (Actual)

June 15, 2018

Last Update Submitted That Met QC Criteria

June 13, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOT-C-104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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