Validation of Imiquimod- and LPS-induced Skin Inflammation Models and Their Application in the Investigation of Azithromycin Concentration in Inflamed, Infected, and Healthy Subcutaneous Tissue

Pro_AZI_IMQ_LPS

This study will investigate the tissue distribution of azithromycin in healthy, artificially inflamed and actually infected tissue of humans.

2024-01-01

2026-01-01

2026-07-01

Not yet recruiting

36

Inclusion Criteria: * • Men and women aged ≥18 and \<55 years * BMI ≥18 and ≤30 kg/m2 * Normal (or clinically irrelevant abnormal) findings in medical history and physical examination * Women with child-bearing potential: use of effective contraception * Laboratory parameters within the given reference range (or abnormal findings which are irrelevant for study purposes in the Investigator's opinion) Exclusion Criteria: * Known or suspected allergy to lipopolysaccharide, imiquimod, or sticking plasters * Only Part 0c: Known or suspected allergy to local anesthetics * History of severe allergic or anaphylactic reactions to any medication • Blood donation within the last 4 weeks before the study * Treatment with an investigational drug within three weeks before the study * Smoking of more than 5 cigarettes per day * Regular use of medication or abuse of alcohol * Use of any medication within one week before the study * Symptoms of a clinically relevant illness in the 3 months before the study * Liver or kidney dysfunction * Pregnancy * History of autoimmune diseases (especially psoriasis) * Other objections to participating in the study in the opinion of the Investigator

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 36, 'type': 'ESTIMATED'}}

2023-12-14