Challenge model development Challenge
Conditions
Sponsors
Hoffmann-La Roche
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male and female subjects, 18 to 45 years of age, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, haematology, blood chemistry, blood serology and urinalysis. In the case of uncertain or questionable results, tests performed during screening may be repeated before enrollment to confirm eligibility or judged to be clinically irrelevant for healthy subjects; 2. Body mass index (BMI) between 18 and 30 kg/m2 and a minimum weight of 50 kg, inclusive; 3. Fitzpatrick skin type I-III (Caucasian); 4. Subjects of childbearing potential must use effective contraception for the duration of the study; 5. Able and willing to give written informed consent and to comply with the study restrictions.
Exclusion criteria
Exclusion criteria: 1. History of pathological scar formation (keloid, hypertrophic scar) or keloids or surgical scars in the target treatment area (lower arm and upper back) that in the opinion of the investigator, would limit or interfere with dosing and/or measurement in the trial; 2. Have any current and / or recurrent pathologically, clinical significant skin condition at the treatment area (lower arm and upper back, i.e. atopic dermatitis); including tattoos; 3. Requirement of immunosuppressive or immunomodulatory medication within 30 days prior to enrolment or planned to use during the course of the study; 4. Known immunodeficiency 5. Use of topical medication (prescription or over-the-counter [OTC]) in local treatment area or any medication that may interfere with the study objectives as judged by the investigator within 30 days of study drug administration, or less than 5 half-lives (whichever is longer) 6. Participation in an investigational drug or device study within 3 months, or 5 half-lives whichever is longer, prior to screening or more than 4 times in the past year. 7. Loss or donation of blood over 500 mL within three months prior to screening or donation of plasma within 14 days of screening 8. Any (medical) condition that would, in the opinion of the investigator, potentially compromise the safety or compliance of the patient or may preclude the patient*s successful completion of the clinical trial. 9. Pregnant, a positive pregnancy test, intending to become pregnant during the study conduct, or breastfeeding. 10. Positive hepatitis B surface antigen (HbsAg), hepatitis C antibody (HCV ab), or human immunodeficiency virus antibody (HIV ab) at screening. 11. A history of ongoing, chronic or recurrent infectious disease 12. Hypersensitivity for dermatological marker at screening 13. Current smoker and/or regular user of other nicotine-containing products (e.g., patches) 14. History of or current drug or substance abuse considered significant by the PI (or medically qualified designee), including a positive urine drug screen. 15. Presence of current, clinically relevant infections 16. Any vaccination within the last 4 weeks before day 1. Intention to receive any vaccination(s) before the last day of follow-up. 17.Prolonged exposure of the investigational skin (lower arm, back) to sunlight (including artificial tanning)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| >Safety: * Treatment-emergent (serious) adverse events ((S)AEs) * Safety labs tests (acute phase proteins (CRP), leukocyte differentiation) * Vital signs (HR, BP) * NRS pain score >Dermal imaging/scoring: * Perfusion by Laser speckle contrast imaging (LSCI) * Erythema by Antera 3D camera * Erythema grading score >Blister exudate analysis * Neutrophils and monocyte subsets | — |
Secondary
| Measure | Time frame |
|---|---|
| >Dermal imaging/scoring * Perfusion * Erythema | — |
Countries
Netherlands
Outcome results
None listed