REGN3918 Single and Multiple dose study
Research type
Research Study
Full title
A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenously and Subcutaneously Administered Human Monoclonal Antibody REGN3918 in Healthy Volunteers
IRAS ID
223642
Contact name
Evelyn Gasparino
Contact email
Sponsor organisation
Regeneron Pharmaceuticals, Inc.
Eudract number
2016-004208-70
Duration of Study in the UK
0 years, 8 months, 6 days
Research summary
REGN3918, a fully human monoclonal immunoglobulin G4P antibody against the complement protein C5, is being developed for the treatment of paroxysmal nocturnal haemoglobinuria and other diseases in which tissue damage is caused by activity of the complement pathway.
The study will be a randomised, double blind, placebo-controlled first in human study of REGN3918. The aim of the study is to evaluate safety, tolerability, pharmacokinetics (how quickly the drug gets into the blood stream and how quickly it is removed from the body) and pharmacodynamics (what effect the drug has on the body) of REGN3918 following single intravenous (IV, injection into a vein) doses and single and multiple subcutaneous (SC, injection into fat underneath the skin) doses.
Approximately 56 subjects will be included in four single ascending dose IV cohorts (Cohorts 1, 2a, 3a and 4), plus two single ascending dose SC cohorts (Cohorts 2b and 3b), followed by one multiple dose cohort (Cohort 5) consisting of an IV loading dose and four repeat SC doses each separated by 7 days. Each cohort will consist of 8 subjects randomized to receive REGN3918 or placebo (6 active: 2 placebo).
In cohorts 1, 2a, 2b and 3a a sentinel group of two subjects (1 active: 1 placebo) will be dosed at least 24 hours before the remainder of the cohort. In cohorts 3b, 4 and 5 subjects will be dosed in two subgroups of four subjects (3 active: 1 placebo) with each subgroup dosed on a different day.
In all cohorts subjects will be admitted to the clinic the day before dosing. Subjects who receive an IV dose will remain in the clinic 24 hours after dosing. Subjects who receive an SC dose will remain in the clinic 8 hours after dosing. All subjects will be followed up for 113 days after dosing.
REC name
London - Brent Research Ethics Committee
REC reference
17/LO/0306
Date of REC Opinion
25 Apr 2017
REC opinion
Further Information Favourable Opinion