Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 27, 2018
First Posted Date  ICMJE March 13, 2018
Last Update Posted Date June 15, 2018
Actual Study Start Date  ICMJE April 1, 2016
Actual Primary Completion Date August 25, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03463044 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2018)
Pharmacokinetics (Maximum Plasma Concentration) [ Time Frame: 8 hours ]
Maximum Plasma Concentration [Cmax]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability and Pharmacokinetic Profiles of MOTREM (LR12) in Healthy Male Subjects
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Condition  ICMJE Healthy Subjects
Intervention  ICMJE
  • Drug: nangibotide
    Continous i.v. infusion
    Other Names:
    • LR12
    • MOTREM
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: MOTREM 1
    Intervention: Drug: nangibotide
  • Experimental: MOTREM 2
    Intervention: Drug: nangibotide
  • Experimental: MOTREM 3
    Intervention: Drug: nangibotide
  • Experimental: MOTREM 4
    Intervention: Drug: nangibotide
  • Experimental: MOTREM 5
    Intervention: Drug: nangibotide
  • Experimental: MOTREM 6
    Intervention: Drug: nangibotide
  • Experimental: MOTREM 7
    Intervention: Drug: nangibotide
  • Experimental: MOTREM 8
    Intervention: Drug: nangibotide
Publications * Cuvier V, Lorch U, Witte S, Olivier A, Gibot S, Delor I, Garaud JJ, Derive M, Salcedo-Magguilli M. A first-in-man safety and pharmacokinetics study of nangibotide, a new modulator of innate immune response through TREM-1 receptor inhibition. Br J Clin Pharmacol. 2018 Oct;84(10):2270-2279. doi: 10.1111/bcp.13668. Epub 2018 Jul 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 12, 2018)
27
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 25, 2016
Actual Primary Completion Date August 25, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03463044
Other Study ID Numbers  ICMJE MOT-C-104
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Inotrem
Study Sponsor  ICMJE Inotrem
Collaborators  ICMJE Richmond Pharmacology Limited
Investigators  ICMJE
Study Director: Valérie Cuvier Inotrem
PRS Account Inotrem
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP