Large volume subcutaneous injection acceptability study
Research type
Research Study
Full title
A study to investigate an acceptable flow rate for large volume subcutaneous injections in healthy volunteers
IRAS ID
249775
Contact name
Stephanie Igwe
Contact email
Sponsor organisation
GlaxoSmithKline
Duration of Study in the UK
0 years, 4 months, 0 days
Research summary
This study is to support the development of a large volume platform injector for the self-administration of future biopharmaceutical medicines. Some of these medicines are expected to require subcutaneous delivery of dose volumes between 5 mL and 8 mL. This exceeds the capability of GlaxoSmithKline’s (GSK) current injectors for self-administration.
The aim of this study is to understand how fast, volumes of up to 8 mL can be injected subcutaneously without causing unacceptable discomfort and to understand how such discomfort might depend upon delivery rate and volume.
Up to 24 male and female healthy volunteers will be randomly allocated to receive varying volumes and rates of normal sterile saline (0.9%), given as a single subcutaneous infusion twice a day. This study will test up to 8 different volumes and/or rates in each volunteer, and will be conducted in up to 5 study visits.
Taking part in the study will not have a direct benefit to participants.The study is sponsored by GSK, and will be conducted in a Medicines and Health Care Products Regulatory Agency (MHRA) accredited clinical research unit in the United Kingdom, with adequate safety and compliance facilities.
REC name
Wales REC 2
REC reference
18/WA/0278
Date of REC Opinion
24 Aug 2018
REC opinion
Further Information Favourable Opinion