Inflammation / Complement activation MedDRA version: 20.0 Level: PT Classification code 10061218 Term: Inflammation System Organ Class: 10018065 - General disorders and administration site conditions
Conditions
Sponsors
Centre for Human Drug Research
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Healthy male subjects, 18 to 65 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, hematology, coagulation, blood chemistry, blood serology and urinalysis. In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization 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 and their partners 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Eligible subjects must meet none of the following exclusion criteria at screening: 1. History of pathological scar formation (keloid, hypertrophic scar) or keloids or surgical scars in the target treatment area that in the opinion of the investigator, would limit or interfere with dosing and/or measurement in the trial; 2. History of skin cancer (basal cell carcinoma, squamous cell carcinoma, melanoma); 3. Have any current and / or recurrent clinically significant skin condition at the treatment area (i.e. atopic dermatitis); including tattoos; 4. History or presence of post-inflammatory hyperpigmentation. 5. Using immunosuppressive or immunomodulatory medication within 30 days prior to enrolment or planned to use during the course of the study; 6. Use of topical medication (prescription or over-the-counter [OTC]) within 30 days of study drug administration, or less than 5 half-lives (whichever is longer) in local treatment area; 7. Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year; 8. Loss or donation of blood over 500 mL within three months prior to screening or donation of plasma within 14 days of screening; 9. 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; 10. Chronic infection with HIV, hepatitis B (HBV) or hepatitis C (HCV). A positive HBV surface antigen (HBsAg) test at screening excludes a subject; 11. A history of ongoing, chronic or recurrent infectious disease; 12. Current smoker and/or regular user of other nicotine-containing products (e.g., patches); 13. History of or current drug or substance abuse considered significant by the PI (or medically qualified designee), including a positive urine drug screen. 14. Previous use of Aldara (IMIQUIMOD cream) 3 weeks prior to the baseline visit; 15. Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks of enrollment. 16. A minimal erythema dose (MED) higher than 355 mJ/cm2 at screening. Applicable for the participants in the UVB-MITT population only.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate complement activation in skin after topical imiquimod challenge • To evaluate complement activation in skin after local UV-B challenge ;Secondary Objective: • To characterize the clinical response to an UV-B and imiquimod challenge • To evaluate the correlation between complement activation and clinical response ;Primary end point(s): • Complement factors in skin biopsies following imiquimod challenge • Complement factors in skin biopsies following UV-B challenge ;Timepoint(s) of evaluation of this end point: Day 0 - EOS | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Perfusion by LSCI • Erythema by Antera 3D and clinical evaluation ;Timepoint(s) of evaluation of this end point: Day 0 - EOS | — |
Countries
Netherlands
Contacts
Public ContactM. Moerland
Centre for Human Drug Research
Outcome results
None listed