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

Healthy Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03463044
• Other study ID #: MOT-C-104
• Status: Completed
• Phase: Phase 1
• Start date: April 1, 2016
• Est. completion date: August 25, 2016

Study information

• Verified date: June 2018
• Source: Inotrem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: August 25, 2016
• Est. primary completion date: August 25, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• nangibotide
Continous i.v. infusion
• Placebo
Placebo

Locations

Country	Name	City	State
United Kingdom	Richmond Pharmacology Ltd.	Croydon

Sponsors (2)

Lead Sponsor	Collaborator
Inotrem	Richmond Pharmacology Limited

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Cuvier V, Lorch U, Witte S, Olivier A, Gibot S, Delor I, Garaud JJ, Derive M, Magguilli-Salcedo 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 Pha — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability: Number of subjects with at least one adverse event	Number of subjects with at least one adverse event	28 days
Secondary	Pharmacokinetics (Maximum Plasma Concentration)	Maximum Plasma Concentration [Cmax]	8 hours