N.a.
Conditions
Interventions
Participants will receive saline and SP by intradermal injection, and histamine
by skin prick.
Sponsors
GlaxoSmithKline Research & Development Limited
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Participants are eligible to be included in the study only if all of the following criteria apply: Age 1. Participant must be 18 to 50 years of age inclusive, at the time of signing the informed consent. Type of Participant and Disease Characteristics 2. Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, ECGs and vital signs. 3. Participants who responded positive to histamine skin prick test and negative to saline injection at screening. 4. Participants with Fitzpatrick skin type I-II (Caucasian). Weight 5. Body weight *50 kg and body mass index (BMI) within the range 19*29.9 kg/m2 (inclusive). Sex Sex and Contraceptive/Barrier Requirements 6. Male participants are eligible to participate in the study - A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: o Is a woman of non-childbearing potential (WONCBP) as defined in Section 10.4 of the protocol: Contraceptive and Barrier Guidance. OR o Is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: Medical Conditions 1. Significant history of or current, cardiovascular (including hypotension, severe hypertension, vasomotor instability), respiratory (including asthma), renal, gastrointestinal, endocrine, haematological, infectious or neurological disorders constituting a risk when taking part in the study or interfering with the interpretation of data. 2. History or presence of significant skin disorder (such as but not limited to chronic urticaria, atopic dermatitis, severe eczema, psoriasis or skin cancer). 3. History of risk for or actual experience of complications from skin biopsy including excess bleeding, infection, or scarring/keloid formation. 4. Abnormal blood pressure as determined by the investigator. 5. Alanine transaminase (ALT) >1.5x upper limit of normal (ULN). 6. Total bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if total bilirubin is fractionated and direct bilirubin 450 msec, based on the mean of triplicate ECGs . NOTE: The QTc is the QT interval corrected for heart rate according to Fridericia*s formula (QTcF). Prior/Concomitant Therapy 9. Use of any form of H1 or H2 antihistamine, tricyclic antidepressants, beta2 agonists, dopamine, or beta blocking agents within 14 days before the first challenge visit through final assessments. 10. Use of topical medications such as but not limited to retinoids, steroids, and transdermal hormone replacement therapies on or near the intended site of application within 8 weeks prior to dosing through treatment follow up. Use of other topical preparations such as those containing vitamins, supplements or herbal within 2 weeks prior to dosing through treatment follow up. 11. Past or intended use of any other non-topical over-the-counter or prescription medication, including herbal medications, within 7 days before the first challenge visit, unless, in the opinion of the investigator and GSK Medical Monitor, the medication will not constitute a risk when taking the study intervention or interfere with the interpretation of data. Prior/Concurrent Clinical Study Experience 12. Participation in the study would result in loss of blood or blood products in excess of 500 mL within 3 months. 13. Current enrolment in any clinical study involving an investigational study intervention or any other type of medical research. 14. Current enrolment or past participation in this study. Diagnostic assessments 15. Presence of Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HbcAb) at screening or within 3 months before the first challenge day. 16. Positive Hepatitis C antibody test result at screening or within 3 months before the first challenge day. NOTE: Subjects with positive Hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C RNA test is obtained 17. Positive Hepatitis C RNA test result at screening or within 3 months before the first challenge day. NOTE: Test is optional and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1 - Wheal response during the 2 h postchallenge period area under the curve (AUC) at each concentration of SP Part 2 - Wheal response during the 2 h postchallenge period (AUC) at each concentration of SP across 2 challenge days | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1 - Wheal response during the 2 h postchallenge period at each concentration of SP (including maximum observed wheal response, time to maximum observed wheal response, time of complete wheal response disappearance) - Flare response during the 2 h postchallenge period at each concentration of SP (including AUC, maximum observed flare response, time to maximum observed flare response, time of complete flare response disappearance) - Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) - Incidence of findings of clinical important changes in: o vital signs o laboratory safety data o 12-lead electrocardiogram (ECG) Part 2 - Wheal response during the 2 h postchallenge period at each concentration of SP across 2 challenge days (including maximum observed wheal response, time to maximum observed wheal response, time of complete wheal response disappearance) - Flare response during the 2 h postchallenge period at each concentration of SP across 2 challenge days (including AUC, maximum observed flare response, time to maximum observed flare response, time of complete flare response disappearance) - Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) - Incidence of findings of clinical important changes in: o vital signs o laboratory safety data o 12-lead ECG | — |
Countries
Netherlands
Outcome results
None listed