Trial | NCT03463044  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    27
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 Started
Apr 01
2016
Primary Completion
Aug 25
2016
Study Completion
Aug 25
2016
Last Update
Jun 15
2018

Drug nangibotide

Continous i.v. infusion

  • Other names: LR12, MOTREM

Drug Placebo

Placebo

Placebo Placebo Comparator

MOTREM 1 Experimental

MOTREM 2 Experimental

MOTREM 3 Experimental

MOTREM 4 Experimental

MOTREM 5 Experimental

MOTREM 6 Experimental

MOTREM 7 Experimental

MOTREM 8 Experimental

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.
No Results Posted