A safety, PK and PD Study of BGB149 in Healthy Subjects
Research type
Research Study
Full title
A Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BGB149 Following Single Dose Administration in Healthy Subjects
IRAS ID
254171
Contact name
Sarah Bussmann
Contact email
Sponsor organisation
BerGenBio ASA
Eudract number
2018-003186-33
Duration of Study in the UK
0 years, 9 months, 14 days
Research summary
This is a Phase I, first-in-human, randomised, double-blind, adaptive, placebo-controlled, single-dose study to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of the study drug, BGB149 in healthy male and female subjects. The main purpose is to see how safe the drug is and how well the body tolerates after single doses, administered by intravenous (IV) infusion. PK evaluate how the study drug is absorbed (taken up by the body), metabolised (chemically broken down), distributed through the body, and excreted (removed from the body). PD assess the effects of the study drug and the way in which the study drug works (mechanism of action). Immunogenicity refers to the formation of antibodies against the study drug. PK, PD and immunogenicity evaluations will be performed on blood samples collected from the research subjects at predefined time points. For further safety monitoring , blood samples will be collected to investigate acute inflammatory and allergic reactions.
The trial will comprise a Screening Visit, an in-house treatment period of 7 days and a follow-up phone call. The maximum duration of participation for each subject is approximately 18 weeks.
Eligible subjects will be allocated to one of 4-6 cohorts, with planned dose levels of BGB149 of 0.1, 0.3, 1.0 and 3.0 mg/kg. Sentinel dosing will be performed when a new dose level is tested. After a cohort was completed, the available safety and PK data will be reviewed prior to dosing the next cohort. As an additional safety measure, subjects will be observed during and after study drug infusion for fever, chills, or other infusion related reactions.
BGB149 is being developed by BerGenBio ASA, Norway, for the management of fibrotic conditions of the lungs, liver, kidney and skin. BGB149 administration has the potential to stop disease progression, with potential benefit to organ function, quality of life and improved survival.
REC name
London - Harrow Research Ethics Committee
REC reference
18/LO/1547
Date of REC Opinion
12 Nov 2018
REC opinion
Further Information Favourable Opinion