A study in healthy volunteers to evaluate the effect of repeated LPS skin challenges in a single individual
- Conditions
- Challenge model developmentChallenge
- Registration Number
- NL-OMON55995
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 8
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.
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>>Safety:<br /><br>* Treatment-emergent (serious) adverse events ((S)AEs)<br /><br>* Safety labs tests (acute phase proteins (CRP), leukocyte differentiation)<br /><br>* Vital signs (HR, BP)<br /><br>* NRS pain score<br /><br><br /><br>>Dermal imaging/scoring:<br /><br>* Perfusion by Laser speckle contrast imaging (LSCI)<br /><br>* Erythema by Antera 3D camera<br /><br>* Erythema grading score<br /><br>>Blister exudate analysis<br /><br>* Neutrophils and monocyte subsets</p><br>
- Secondary Outcome Measures
Name Time Method <p>>Dermal imaging/scoring<br /><br>* Perfusion<br /><br>* Erythema</p><br>