A dermal inflammatory challenge study to evaluate complement activation in healthy volunteers

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 15

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.

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• Complement factors in skin biopsies following imiquimod challenge<br /><br>• Complement factors in skin biopsies following UV-B challenge</p><br>

Secondary Outcome Measures