NL-OMON55995
Completed
Not Applicable
A study in healthy volunteers to evaluate the effect of repeated LPS skin challenges in a single individual - Effect of repeated local LPS challenges in healthy volunteers
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Challenge model development
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 8
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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,
- •3\. Fitzpatrick skin type I\-III (Caucasian);
- •4\. Subjects of childbearing potential must use effective contraception for the
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
Outcomes
Primary Outcomes
Not specified
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