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A Placebo-controlled Safety and Tolerability Study of Intravenous (IV) and Subcutaneous (SC) AZD1163 in Healthy Volunteers
A Placebo-controlled Safety and Tolerability Study of Intravenous (IV) and Subcutaneous (SC) AZD1163 in Healthy Volunteers
CompletedPhase 1
Sponsor: AstraZeneca
Conditions: Healthy Volunteers
Interventions: AZD1163, Placebo
Countries: United States, Germany
A study to demonstrate the safety and tolerability of AZD1163 when administered intravenously and subcutaneously in healthy participants.
Eligibility overview
Sex: ALL
Age: 18 Years to 55 Years
Healthy volunteers: Yes
Study type: INTERVENTIONAL
Eligibility criteria
Inclusion Criteria: * Healthy male and female participants with suitable veins for cannulation or repeated venipuncture * All females must have a negative pregnancy test * Females of childbearing potential must not be lactating and, if heterosexually active, agree to taking approved method/s of contraception * BMI between 18 and 32 kg/m\^2 and weigh at least 45 kg Exclusion Criteria: * Has received another new chemical entity * History of any disease or disorder which may put participant at risk in the study * Current or recurrent disease of clinical significance * Medical history of malignancies except for cervical carcinoma and non-melanoma skin cancer (NMSC) * Any clinically important illness, medical/procedure, or trauma * Any clinically important abnormalities in clinical chemistry, hematology, or urinalysis result at screening * Any positive result on screening for serum hepatitis B surface antigen (HbsAg), hepatitis B core antibody (HbcAb), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) * History of latent or active tuberculosis (TB) or exposure to endemic areas * Evidence of active TB or untreated/inadequately/inappropriately treated for latent TB * Positive testing for Covid-19 prior to dosing, case of Covid-19 within 4 weeks, or long-term Covid-19-related sequelae * Active systemic bacterial, viral, or fungal infection within 14 days prior to dosing or presence of fever * Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12-lead electrocardiogram (ECG), and any clinically important abnormalities in the 12-lead ECG * Known or suspected history of alcohol or drug abuse or excessive intake of alcohol * History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity
Locations (3)
- Glendale, California, United States
- Brooklyn, Maryland, United States
- Berlin, Germany