A study to demonstrate the safety and tolerability of AZD1163 when administered intravenously and subcutaneously in healthy participants.

This is a first time in human (FTiH), placebo-controlled, sequential study in healthy participants. This study consists of two parts: Part 1 Single Ascending Dose (SAD) and Part 2 Multiple Ascending Dose (MAD). Part 1 will contain 9 cohorts, 8 intravenously (IV) administered dose levels and 1 subcutaneously (SC) administered dose level of AZD1163. Part 2 will contain 2 SC dose levels of AZD1163. A sentinel dosing approach will be taken. Each participant will be involved in the study for approximately 70 weeks.

The study will comprise of:

• A Screening Period of maximum 28 days for both Part 1 and Part 2.
• Part 1: A single dose of AZD1163 with an in-clinic period of 7 to 8 days.
• Part 2: Two doses of AZD1163, given 2 weeks apart both with an in-clinic period of 7 to 8 days.
• An outpatient Follow-up Period of approximately 15 months.

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

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.