A dermal inflammatory challenge study to evaluate complement activation in healthy volunteers

Centre for Human Drug Research0 sites15 target enrollmentJanuary 11, 2021

Overview

No summary available.

Registry

who.int

Start Date

January 11, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Sponsor

•1\.Healthy male subjects, 18 to 65 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, coagulation, blood chemistry, blood serology and urinalysis. In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization 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, inclusive;
•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;
•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 15
•F.1\.3 Elderly (\>\=65 years) no

•Eligible subjects must meet none of the following exclusion criteria at screening:
•1\.History of pathological scar formation (keloid, hypertrophic scar) or keloids or surgical scars in the target treatment area that in the opinion of the investigator, would limit or interfere with dosing and/or measurement in the trial;
•2\.History of skin cancer (basal cell carcinoma, squamous cell carcinoma, melanoma);
•3\.Have any current and / or recurrent clinically significant skin condition at the treatment area (i.e. atopic dermatitis); including tattoos;
•4\.History or presence of post\-inflammatory hyperpigmentation.
•5\.Using immunosuppressive or immunomodulatory medication within 30 days prior to enrolment or planned to use during the course of the study;
•6\.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;
•7\.Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year;
•8\.Loss or donation of blood over 500 mL within three months prior to screening or donation of plasma within 14 days of screening;
•9\.Any (medical) condition that would, in the opinion of the investigator, potentially compromise the safety or compliance of the patient or may preclude the patient’s successful completion of the clinical trial;