NCT03463044

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Inotrem · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

This was a dose escalation study in healthy volunteers to evaluate the safety and pharmacokinetics of nangibotide in humans

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	nangibotide	Continous i.v. infusion
DRUG	Placebo	Placebo

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-08-25
• Completion: 2016-08-25
• First posted: 2018-03-13
• Last updated: 2025-02-10
• Results posted: 2025-02-10

Locations

1 site across 1 country: United Kingdom