GlaxoSmithKline
The objectives of this enabling study are to characterize the wheal and flare responses over time following skin challenges with ascending concentrations of Substance P. This will be a 2-part study: Part 1 will aid in the understanding of the wheal and flare responses following Substance P. Part 2 will investigate the variability of the responses. Participants may be enrolled into Part 1 or Part 2, not both.
Skin Diseases
Substance P
Normal Saline
Histamine
Not Applicable
Study Type : | Interventional |
Estimated Enrollment : | 32 participants |
Masking : | None (Open Label) |
Masking Description : | It is an open-label study. |
Primary Purpose : | Other |
Official Title : | An Open Label, Single Centre, Enabling Study to Investigate the Optimum Method for Use of Intradermal Substance P as a Challenge Agent in Healthy Participants |
Actual Study Start Date : | March 2, 2021 |
Estimated Primary Completion Date : | July 21, 2021 |
Estimated Study Completion Date : | July 21, 2021 |
Arm | Intervention/treatment |
---|---|
Experimental: Substance P challenge in Part 1 Eligible participants will receive control challenge with saline and histamine, followed by challenge with ascending concentrations of Substance P. Part 1 will include a single challenge visit. |
Drug: Substance P Drug: Normal Saline Drug: Histamine |
Experimental: Substance P challenge in Part 2 Eligible participants will receive control challenge with saline and histamine, followed by challenge with ascending concentrations of Substance P. Part 2 will include two challenge visits. |
Drug: Substance P Drug: Normal Saline Drug: Histamine |
Ages Eligible for Study: | 18 Years to 50 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
GSK Investigational Site
Leiden, Netherlands, 2333 CL