Assess the Safety, Tolerability and Pharmacokinetics of AZD5055 Following Single and Multiple Asc… (NCT05134727) | Clinical Trial Compass
CompletedPhase 1
Assess the Safety, Tolerability and Pharmacokinetics of AZD5055 Following Single and Multiple Ascending Doses in Healthy Participants
United States63 participantsStarted 2021-11-18
Plain-language summary
This is a phase I, First-in-Human study in healthy participants, performed at a single study center, consisting of 2 parts: Part 1 is a single ascending dose (SAD) study and Part 2 is a multiple ascending dose (MAD) study.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion Criteria
* Healthy male and female (of non-childbearing potential) subjects aged Part 1 (SAD): 18 - 55 years; Part 2 (MAD): 18 - 55 for male and 18 -49 for females, inclusive, with suitable veins for cannulation or repeated venipuncture.
* Female subjects must have a negative pregnancy test.
* Have a BMI between 18 and 30 kg/m2 inclusive and weigh at least 50 kg.
* Male subjects and their women of childbearing potential partners must be willing to use highly effective contraception measures and must refrain from donating sperm or fathering a child from the first day of dosing until 17 days after the last dose of Investigational medicinal product.
Exclusion Criteria
* History of any clinically important disease or disorder, or a major medical/surgical procedure or significant trauma within 4 weeks of the first dose of IMP.
* Untreated tuberculosis (TB) or a positive result for the interferon gamma release assay (ie, QuantiFERON TB Gold).
* A positive result for serum hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibody, at the Screening Visit.
* Ongoing acquired or inherited immunodeficiency disorders, including but not limited to HIV or common variable immunodeficiency, or the subject is taking immune replacement therapy.
* Individuals with chronic infections (eg, urinary tract infection) or who are at increased risk of infection (eg, surgery, trauma, severe dental disease, or significant infection) within 30 days of screening.
* Histor…
What they're measuring
1
Part 1: Number of participants with adverse events (AEs)
Timeframe: Until Follow-up (7 days post dose) (approximately up to 53 days)
2
Part 2: Number of participants with AEs
Timeframe: Until follow-up (45 days post-last dose) (approximately up to 89 days)