Phase
Condition
N/ATreatment
AZD4144- Part A
Placebo- Part A
Rosuvastatin and AZD4144 Part C
Clinical Study ID
Ages 18-55 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
All females must have a negative pregnancy test at the Screening Visit and onadmission to the Clinical Unit.
Females of childbearing potential must not be lactating and if heterosexually activemust agree to use an approved method of highly effective contraception.
Females of non-childbearing potential must be confirmed at the Screening Visit.
Sexually active fertile male participants with partners of childbearing potentialmust adhere to the contraception methods.
Have a BMI between 18 and 32 kg/m2 inclusive at both Screening and Admission andweigh at least 45 kg at Screening.
For healthy Japanese cohorts (Part A2 and Part B2): healthy male and femaleparticipants are to be Japanese, defined as having both parents and 4 grandparentswho are Japanese. This includes second and third generation participants of Japanesedescent whose parents or grandparents are living in a country other than Japan.
For healthy Chinese cohort (Part A3): healthy male and female Chinese participantsfor whom both parents and all grandparents are Chinese and not lived outside ofChina for more than 10 years.
Exclusion
Exclusion Criteria:
History of any clinically important disease or disorder or presence ofgastrointestinal, hepatic, or renal disease or any other condition known tointerfere with absorption, distribution, metabolism, or excretion of drugs.
Any clinically important illness, medical/surgical procedure, or trauma.
Clinically significant serious active and chronic infections.
Any history or evidence of TB (active or latent).
Known history of primary immunodeficiency (congenital or acquired) or an underlyingcondition that predisposes to infection.
Bacillus Calmette Guérin vaccine within one year prior to signing the ICF.
Any abnormal laboratory values at the Screening Visit or on Admission to theClinical Unit.
Any positive result on Screening for serum Hepatitis B surface antigen (HBsAg),anti-Hepatitis B core (HBc), hepatitis C antibody, or Human immunodeficiency virus (HIV).
Any clinically important abnormalities in ECG.
History of severe allergy/hypersensitivity or ongoing clinically importantallergy/hypersensitivity.
Known hypersensitivity to furosemide and rosuvastatin (for Part C only)
History of alcohol abuse or excessive intake of alcohol or current smokers or thosewho have smoked or used nicotine products.
Use of drugs with enzyme inducing properties or of any prescribed or nonprescribedmedication or of systemic hormonal contraceptives.
Clinical signs and symptoms consistent with COVID-19.
Study Design
Study Description
Connect with a study center
Research Site
Glendale, California 91206
United StatesActive - Recruiting
Research Site
Brooklyn, Maryland 21225
United StatesActive - Recruiting
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