A Phase I study of AZD3152 in adult participants

Exclusion Criteria

• Participants are excluded from the study if any of the following criteria apply:
• 1 Women who are pregnant, lactating, or of childbearing potential and not using a highly effective method of contraception or abstinence from at least 4 weeks prior to study intervention administration and until at least 6 months after study intervention administration.
• 2 Known hypersensitivity to any component of the study intervention.
• 3 Previous hypersensitivity, infusion-related reaction or severe adverse reaction following administration of a mAb.
• 4 Acute (time-limited) or febrile (temperature ≥ 38.0°C) illness/infection on day prior to or day of planned dosing; participants excluded for transient acute illness may be dosed if illness resolves within the screening period or may be rescreened once.
• 5 Receipt of immunoglobulin or blood products within 6 months prior to randomization.
• 6 SARS-CoV-2 or COVID-19:
• a) COVID-19 within 3 months prior to randomization (confirmed either by laboratory testing or using a rapid test).
• b) Previous receipt of a mAb against SARS-CoV-2.
• c) Receipt of a COVID-19 vaccine within 3 months prior to randomization.
• d) Receipt of a COVID-19 antiviral for prophylaxis within at least 2 weeks prior to randomization.
• 7 Receipt of any IMP in the preceding 90 days or expected receipt of IMP during the period of study follow-up, or concurrent participation in another interventional study.
• 8 Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 30 days prior to randomization.
• 9 Clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections/IV infusions or venipuncture.
• 10 History of malignancy other than treated non-melanoma skin cancers or locally-treated cervical cancer in previous 5 years.
• 11 Any condition that, in the opinion of the Investigator, might compromise participant safety or interfere with evaluation of the study intervention or interpretation of participant safety or study results.
• 12 Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy, including any course of glucocorticoid therapy exceeding 2 weeks of prednisone or equivalent at a dose of 20 mg daily or every other day within 6 months prior to screening.
• 13 HIV infection, active infection with hepatitis B or C:
• a) Positive test for hepatitis B surface antigen and/or anti-HBc antibody: participants who test positive for HBsAg and/or anti-HBc antibody may be enrolled if their hepatitis B virus DNA test result is negative.
• b) Positive test for anti-hepatitis C antibody: participants who test positive for anti-hepatitis C antibody may be enrolled if their hepatitis C virus RNA test result is negative in the absence of cirrhosis.
• 14 Serum creatinine, alanine aminotransferase, or aspartate aminotransferase above the 1.5 × ULN at screening.
• 15 Any laboratory value in the screening panel that, in the opinion of the Investigator, is clinically significant or might confound analysis of study results.
• 16 Employees of AstraZeneca involved in planning, executing, supervising, or reviewing the AZD3152 program, clinical study site staff, or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
• 17 Alcohol or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion.
• 18 Deprived of freedom by an administrative or court order, or in emergency setting, or hospitalized involuntarily.
• 19 Any condition that, in the opinion of the Investigator, might compromise participant safety or interfere with evaluation of the study intervention or interpretation of participant safety or study results.