Development of a dermal TLR4 challenge in healthy volunteers.

Completed

• Conditions: Skin inflammation; 10014982

• Registration Number: NL-OMON46799
• Lead Sponsor: Centre for Human Drug Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 18

Inclusion Criteria

1. Healthy male 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, hematology, blood chemistry, blood serology and urinalysis;
2. Body mass index (BMI) between 18 and 30 kg/m2, inclusive, and with a minimum weight of 50 kg;
3. Fitzpatrick skin type I-III (Caucasian);
4. 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. Any disease associated with immune system impairment, including auto-immune diseases, HIV and transplantation patients;
2. Any vaccination within the last 3 months;
3. Family history of psoriasis;
4. History of pathological scar formation (keloid, hypertrophic scar);
5. Have any current and / or recurrent pathologically, clinical significant skin condition at the treatment area (i.e. atopic dermatitis);
6. Hypersensitivity for dermatological marker at screening;
7. Requirement of immunosuppressive or immunomodulatory medication within 30 days prior to enrollment or planned to use during the course of the study;
8. Excessive sun exposure or a tanning booth within 3 weeks of enrollment;
9. Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year;
10. Loss or donation of blood over 500 mL within three months prior to screening. Or the donation of plasma within 14 days prior to screening;
11. Current smoker and/or regular user of other nicotine-containing products (e.g., patches);
12. History of or current drug or substance abuse considered significant by the PI (or medically qualified designee), including a positive urine drug screen.

Study & Design

• Study Type: Interventional
• Study Design: Not specified