During the Study. The events below will take place throughout the study. If you would like to know when exactly these will take place, please ask the study staff. • You will be asked about any updates to your medical history. This includes medication, drug, alcohol, and tobacco use • Physical exam(s) will be done • The use of proper birth control will be confirmed/reviewed • Xxxxx xxxxx will be measured. Your oral temperature may also be measured • ECGs will be collected o It may be necessary to shave or trim hair on your chest so that the patches for the ECGs will stick to your skin o Your chest may be marked with a pen to identify the correct areas for ECG patch placement • You will be asked: “How do you feel?” each day • An intravenous (IV) catheter may be placed in a vein in one of your arms for blood collection • The study investigator may decide to do an alcohol breath test at any time • You may complete a COVID-19 questionnaire • You may be tested for COVID-19 o COVID-19 testing will be done by collection of a swab sample • Blood and urine samples will be collected at various times throughout the study o Safety Labs: The blood and urine samples will be used for safety labs including the following: ▪ Urine samples to test for drugs of abuse ▪ Blood pregnancy test for females able to have children. Pregnancy tests may be performed at the discretion of the study investigator in all females o Any leftover serum or plasma (components of blood) from the safety lab samples may be stored and used to assess exploratory safety biomarkers or unexpected safety findings ▪ Biomarkers are natural substances in your body that can be used to show how your body works ▪ Samples to be used for this purpose will be kept for up to 1 year following completion of this study o Study Drug Levels: Blood samples will also be used to measure the levels of study drug. Blood will also be used to measure the blood to plasma ratio of the study drug (the amount of study drug in the whole blood compared to that in the plasma) ▪ As part of understanding how your body absorbs, distributes, and gets rid of the study drug, the samples may also be used for the following: ⮚ Metabolite identification (by-products or end products of a drug produced as the body processes a drug) ⮚ Evaluate safety or efficacy (ability to produce a desired effect) aspects related to any concerns during or after the study ⮚ Check the laboratory test which measures the study drug ⮚ Other internal exploratory purposes • You will re...
During the Study. The events below will take place throughout the study. If you would like to know when exactly these will take place, please ask the study staff. • You will be asked about any updates to your medical history. This includes medication, drug, alcohol, and tobacco use • Physical exams, including skin exam o Photographs of the skin may be taken if the study clinician thinks it is needed. Photographs are photographic images of the skin that the study team may take of you during the study. You will not be identified in these photographs. However, if you have any markings on the area of your skin photographed, like a tattoo, those markings may appear in the photographs. Pfizer will own these photographs. The photographs will be used and shared along with your study records, as described in this consent document. In addition, the photographs may be used in publications, presentations, brochures, or other ways. The photographs may be used along with text, graphics, or audio materials. You will not be identified by name in any use of the photographs. By signing this consent document, you are giving permission for the study staff to take these types of photographic images and for the uses described above. • The use of proper birth control will be confirmed/reviewed (males only) • Xxxxx xxxxx. Your oral temperature may also be measured • Weight will be measured (Part B only) • ECGs will be collected o It may be necessary to shave or trim hair on your chest so that the patches for the ECGs will stick to your skin o Your chest may be marked with a pen to identify the correct areas for ECG patch placement • Continuous heart monitoring will be done for at least 8 hours after each dose (Part A only, except for Japanese dosing group, if done). There will also be a period of at least 2 hours (Day -1, Period 1 only) where monitoring will be done before the first dose o This involves the attachment of a small box like unit (transmitter) to your chest o The box is attached by a few wires (similar to those of an ECG) o The monitor sends information about your heart’s activity by a radio signal to a monitor o You may not sleep during the 2 hours of continuous monitoring done before dosing o You will need to stay in the procedure room for at least 4 hours after dosing while attached to the monitor o You will need to keep the box with you during the monitoring period o You will be asked to minimize activity while attached to the monitor • You will be asked: “How do you feel?” each d...
During the Study. Study progress reports, detailing the number of sites who have signed the contract as well as the dates of initiation of the sites, financial information, status of monitoring, status of data entry, data query generation and query resolution Any publication on the Study whether in a journal, lay press, website, scientific meeting as in section 15.4.1 Any updates to the documents mentioned above Before Data Base Lock: Study Results Dissemination Plan
During the Study. Continue your routine cleansing regimen • Continue your routine cosmetics and skin care products • Avoid exposing your target and non-target SKs to excessive natural or artificial ultraviolet radiation (e.g., sunlight, tanning beds) and use sunscreen on the target or non-target SKs, if excessive exposure cannot be avoided • The use of the following therapies to treat any of the target or non-target lesions are prohibited o Retinoids (topical) o Corticosteroids (topical) o LASER, light or other energy-based therapy o Liquid nitrogen, electrodesiccation, curettage, imiquimod, ingenol mebutate o Microdermabrasion or superficial chemical peels o Antibiotics (topical) • Use of self-xxxxxx lotions/sprays are prohibited during the study • Bring this subject instruction sheet with you to each visit
