Safety, tolerability and PK of IV MOTREM in healthy male volunteers
Research type
Research Study
Full title
A Phase I, randomized, placebo controlled study to assess the safety, tolerability and pharmacokinetic profiles of ascending, single, intravenous doses of MOTREM (LR12) in healthy male subjects
IRAS ID
170095
Contact name
Ulrike Lorch
Contact email
Sponsor organisation
INOTREM SA
Eudract number
2015-005654-35
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 3 months, 21 days
Research summary
We are conducting a First-in-Human trial with a medicine known as MOTREM(LR12) being developed for the treatment of sepsis (whole-body inflammatory response to an infection) and myocardial infarction (heart attack) which are conditions that can be life-threatening. MOTREM(LR12) has the potential to decrease inflammation responsible for the start and progression of sepsis and degree of myocardial infarction.\n\nThe primary objective is to assess the safety and tolerability of single doses of MOTREM(LR12) in healthy volunteers. We will also measure how much MOTREM(LR12) is found in the blood (pharmacokinetics) and investigate the presence of anti-drug-antibodies in the blood.\n\nIt is anticipated that between 26 and 72 healthy volunteers including optional groups will be included. The study will consist of 2 parts: in Part A (groups 1 and 2) a single intravenous (iv) loading MOTREM(LR12) dose will be given over 15 min and in Part B (groups 3-8) a single iv loading MOTREM(LR12) dose will be given over 15 min followed by 7h and 45 min of continued infusion.\n\nThe time commitment required from each volunteer is 42 days including a screening visit, an in-patient period of 3 days / 2 nights and 2 follow-up visits. The study will be conducted at Richmond Pharmacology Ltd. The Study is funded by INOTREM SA (the Sponsor), which is a pharmaceutical company based in Paris, France.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
16/SC/0034
Date of REC Opinion
1 Mar 2016
REC opinion
Further Information Favourable Opinion