Safety and PK of single doses of GBR 900 in healthy adults
Research type
Research Study
Full title
A Phase 1, Double Blind, Randomised, Placebo Controlled, Study to Evaluate the Safety and Pharmacokinetics of Single Intravenous Doses of GBR 900 in Adult Healthy Volunteers
IRAS ID
147739
Contact name
Jim Bush
Contact email
Sponsor organisation
on behalf of: Glenmark Pharmaceuticals SA
Eudract number
2013-005480-31
ISRCTN Number
n/a
Research summary
This is a first-in-human study of GBR 900, an antibody being developed for the treatment of pain. 56 healthy persons (men, and/or women who cannot bear children) will be studied in 7 groups of 8 subjects. After a screening visit to ensure eligibility via defined inclusion and exclusion criteria, eligible subjects who wish to volunteer will be admitted to a residential drug research unit. After further clinical checks subjects will be administered a single dose of GBR 900 or placebo (a dummy treatment consisting of the same sodium chloride solution as is used to dilute the active drug) by means of a slow infusion into a vein; neither the subject nor the clinical team will know whether the subject receives active or placebo (“double-blind”). The choice of active versus placebo is made at random (like tossing a coin, but with more subjects allocated to active treatment than to placebo). The first group of subjects will receive a much lower dose of GBR900 than is expected to have any biological effect. All subjects randomised to active medication in each group will receive the same dose on day 1, and all subjects will remain in the unit under close observation until day 3. Further outpatient follow-up visits will occur up to day 71. A safety review committee will review the information on each group, and provided the dose was safe and well tolerated the next group will be dosed with a higher dose - planned doses are specified in the protocol. The main objects of the study are to explore the relation between GBR 900 and any adverse effects (safety), between dose and the plasma concentrations of GBR900 at intervals after dosing ("pharmacokinetics") and whether antibodies develop to GBR 900 ("immunogenicity"). This information is needed for the further development of GBR 900.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
14/LO/0503
Date of REC Opinion
9 Jun 2014
REC opinion
Further Information Favourable Opinion