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

NCT03463044 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2025-02-10

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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

Conditions

  • Healthy Subjects

Interventions

DRUG

nangibotide

Continous i.v. infusion

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Richmond Pharmacology Limited

    collaborator INDUSTRY
  • Inotrem

    lead INDUSTRY

Principal Investigators

  • Valérie Cuvier · Inotrem

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-01
Primary Completion
2016-08-25
Completion
2016-08-25

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03463044 on ClinicalTrials.gov