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

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ClinicalTrials.gov Identifier: NCT03463044
Recruitment Status : Completed
First Posted : March 13, 2018
Last Update Posted : June 15, 2018
Sponsor:
Collaborator:
Richmond Pharmacology Limited
Information provided by (Responsible Party):
Inotrem

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: nangibotide Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : April 1, 2016
Actual Primary Completion Date : August 25, 2016
Actual Study Completion Date : August 25, 2016

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Pharmacokinetics (Maximum Plasma Concentration) [ Time Frame: 8 hours ]
    Maximum Plasma Concentration [Cmax]



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03463044


Locations
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United Kingdom
Richmond Pharmacology Ltd.
Croydon, United Kingdom
Sponsors and Collaborators
Inotrem
Richmond Pharmacology Limited
Investigators
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Study Director: Valérie Cuvier Inotrem

Publications of Results:
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Responsible Party: Inotrem
ClinicalTrials.gov Identifier: NCT03463044     History of Changes
Other Study ID Numbers: MOT-C-104
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No