Topical challenge with omiganan and imiquimod in healthy volunteers

Phase 1

• Conditions: one; MedDRA version: 19.1Level: LLTClassification code 10062249Term: Skin inflammationSystem Organ Class: 100000004858; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2016-004702-34-NL
• Lead Sponsor: Cutanea Life Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-26
• Last Update Posted: 22 May 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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.
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.Subjects and their partners of childbearing potential must use effective contraception, for the duration of the study and for 3 months after the last dose.
5.Able and willing to give written informed consent and to comply with the study restrictions.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Any disease associated with immune system impairment, including auto-immune diseases, HIV and transplantation patients
2.Family history of psoriasis
3.History of pathological scar formation (keloid, hypertrophic scar)
4.Have any current and / or recurrent pathologically, clinical significant skin condition.
5.Previous use of imiquimod/ resiquimod/ gardiquimod
6.Known hypersensitivity to the (non)investigational drug, drugs of the same class, or any of their excipients.
7.Hypersensitivity for dermatological marker at screening
8.Requirement of immunosuppressive or immunomodulatory medication within 30 days prior to enrollment or planned to use during the course of the study.
9.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
10.Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks of enrollment.
11.Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year.
12.Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening
13.Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified