Clinical trial NCT03071679: Topical Challenge With Omiganan and Imiquimod in Healthy Volunteers
Official title: A Randomized, Evaluator-blinded, Vehicle-controlled Study to Explore the Pharmacodynamic Effects of Omiganan and Omiganan in Combination With Imiquimod in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Maruho Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-03-07
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: This study has a randomized, evaluator-blinded, vehicle- controlled study to assess the pharmacodynamics of omiganan and omiganan with imiquimod in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* 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.
* Body mass index (BMI) between 18 and 30 kg/m2, inclusive, and with a minimum weight of 50 kg.
* Fitzpatrick skin type I-III (Caucasian)
* 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.
* Able and willing to give written informed consent and to comply with the study restrictions.

Exclusion Criteria:

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

Primary outcomes:
measure: Clinical Evaluation
timeFrame: 6 Days
measure: Pharmacodynamic (Biomarkers)
timeFrame: Within 2 Weeks
measure: Pharmacodynamic (Histology)
timeFrame: Within 2 Weeks
measure: Pharmacodynamic (Immunohistochemistry)
timeFrame: Within 2 Weeks
measure: Pharmacodynamic (TAP)
timeFrame: Within 6 Days
measure: pharmacodynamic (LSCI)
timeFrame: Within 6 Days
measure: Pharmacodynamic (Colorimetry)
timeFrame: Within 6 Days
measure: Pharmacodynamic (Photography)
timeFrame: Within 2 Weeks
measure: Pharmacodynamic (Thermography)
timeFrame: Within 2 Weeks
Secondary outcomes:
measure: Local tolerability
timeFrame: 2 Weeks
measure: Safety (AE)
timeFrame: 2 Weeks
measure: Safety (Vital Signs)
timeFrame: 2 Weeks
measure: Safety (Laboratory Safety Testing)
timeFrame: 2 Weeks
measure: Safety (ECG)
timeFrame: Within 3 Weeks
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: LUMC/Centre for Human Drug Research
Study officials:
affiliation: Centre for Human Drug Research
name: J. (Koos) Burggraaf, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: