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

NCT03463044 | Completed Phase 1 Results DMC

• 1 other identifier: MOT-C-104
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability: the Number of Subjects Experiencing Treatment Emergent Adverse Events

  The number of subjects experiencing treatment emergent adverse events was collected to assess the safety and tolerability of MOTREM (LR12) in comparison with placebo.

  30-44 days

Secondary Outcomes (9)

• Pharmacokinetics (Maximum Plasma Concentration)

  Maximum Plasma Concentration (Cmax) was assessed only for Groups 3-8 who received loading dose over 15 min and maintenance dose over 7 h and 45 min. Cmax is determined over a period of time starting from predose to 10h after start of the loading dose.

• Statistical Analysis of LR12 PK Parameters: Steady State Concentration During the Maintenance Infusion (Cavg30-465)

  Cavg30-465 was assessed only for Groups 3-8 who received loading dose over 15 min and maintenance dose over 7 h and 45 min. Cavg30-465 is determined over a period of time starting from predose to 10h after start of the loading dose.

• Statistical Analysis of LR12 PK Parameters: t1/2

  t1/2 was assessed only for Groups 3-8 who received loading dose over 15 min and maintenance dose over 7 h and 45 min. t1/2 is determined over a period of time starting from 7 h and 45 min to 10h after start of the loading dose (decaying period).

• Statistical Analysis of LR12 PK Parameters: AUC0-t

  AUC0-t was assessed only for Groups 3-8 who received loading dose over 15 min and maintenance dose over 7 h and 45 min. AUC0-t is determined over a period of time starting time zero (predose) to the time of last observed concentration (t).

• Statistical Analysis of LR12 PK Parameters: AUC0-∞

  AUC0-∞ was assessed only for Groups 3-8 who received loading dose over 15 min and maintenance dose over 7 h and 45 min. AUC0-∞ is determined over a period of time starting time zero (predose) to infinity (cf. extrapolation formula in the above section).

Study Arms (9)

Placebo

PLACEBO COMPARATOR

Matched placebo

Drug: Placebo

MOTREM 1

EXPERIMENTAL

nangibotide dose 1

Drug: nangibotide

MOTREM 2

EXPERIMENTAL

Nangibotide dose 2

Drug: nangibotide

MOTREM 3

EXPERIMENTAL

Nangibotide dose 3

Drug: nangibotide

MOTREM 4

EXPERIMENTAL

Nangibotide dose 4

Drug: nangibotide

MOTREM 5

EXPERIMENTAL

Nangibotide dose 5

Drug: nangibotide

MOTREM 6

EXPERIMENTAL

Nangibotide dose 6

Drug: nangibotide

MOTREM 7

EXPERIMENTAL

Nangibotide dose 7

Drug: nangibotide

MOTREM 8

EXPERIMENTAL

Nangibotide dose 8

Drug: nangibotide

Interventions

nangibotide DRUG

Continous i.v. infusion

Also known as: LR12, MOTREM

MOTREM 1; MOTREM 2; MOTREM 3; MOTREM 4; MOTREM 5; MOTREM 6; MOTREM 7; MOTREM 8

Placebo DRUG

Placebo

Also known as: matched placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy male
• ≥18 to ≤45 years old
• Body mass index (BMI) between 18-30 kg/m² inclusive
• Written informed consent to participate.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inotrem: lead
• Richmond Pharmacology Limited: collaborator

Study Sites (1)

Richmond Pharmacology Ltd.

Croydon, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 29885068 RESULT

MeSH Terms

Interventions

nangibotide

Limitations and Caveats

None reported.

Results Point of Contact

• Title: Executive VP Research and Medical Sciences, INOTREM SA
• Organization: INOTREM SA

jjg@inotrem.com

30 62 86 51

Study Officials

• Valérie Cuvier

  Inotrem

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 13, 2018
• Study Start: April 1, 2016
• Primary Completion: August 25, 2016
• Study Completion: August 25, 2016
• Last Updated: February 10, 2025
• Results First Posted: February 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)