Study to Assess the Safety, Tolerability, and Pharmacokinetics (Movement of Drugs Within the Body) of AZD2693 in Healthy Participants

A Randomised, Single-Blind, Placebo-Controlled, Phase I Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD2693 Following Multiple Subcutaneous Dose Administration in Healthy Participants

This Phase I, randomised, single-blind, placebo-controlled study has been designed to assess the safety, tolerability, and pharmacokinetics (PK) of AZD2693 following subcutaneous (SC) administration of AZD2693 in healthy participants

The study will be performed at a single study center in Japan.

The study will comprise of following periods:

• Screening Period of maximum 28 days.
• An 8-week Treatment Period during which participants will be randomized to receive multiple doses of AZD2693 or placebo at the study center.
• A Follow-up Period of 15 weeks post last dose of study intervention consisting of 8 Follow-up Visits.

Participants will be enrolled in 4 consecutive cohorts of 11 participants where 8 participants will be randomized to receive AZD2693 and 3 participants will be randomized to receive placebo.

A participant is considered to have completed the study if the participant has completed all phases of the study including the last visit.

Inclusion Criteria:

• Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
• Participants who are of Japanese ethnicity (Japanese participant is defined as having both parents and 4 grandparents who are ethnically Japanese and this also includes second and third generation Japanese whose parents or grandparents are living in a country other than Japan)
• Participants who are of Non-Asian ethnicities. A Non-Asian Participant is defined as having both parents and grandparents who are ethnically Non-Asian.
• Body mass index within the range 18 to 32 kg/m^2
• Male and/or female participants of non-child bearing potential

Exclusion Criteria:

• History of any clinically important disease or disorder
• History or presence of gastrointestinal, hepatic, or renal disease or condition known to interfere with absorption, distribution, metabolism or excretion of drugs
• Participants with known autoimmune disease or on-treatment with immune-modulatory drugs
• Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first dose of study intervention
• Any clinically significant cardiovascular event within the last 6 months prior to the Screening Visit
• Any clinically important abnormalities in clinical chemistry, haematology or urinalysis results and any abnormal vital signs
• Any clinically important abnormalities in rhythm, conduction or morphology of the resting electrocardiogram (ECG) and any clinically important abnormalities in the 12-Lead ECG
• Blood dyscrasias with increased risk of bleeding including idiopathic thrombocytopenic purpura and thrombotic thrombocytopenic purpura or symptoms of increased risk of bleeding
• History of major bleed or high-risk of bleeding diathesis
• Participants with a positive diagnostic nucleic acid test for Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), at Screening Visit. Participants who test positive for Coronavirus disease 2019 (COVID-19) at Screening Visit
• Participants with a significant COVID-19 illness within 6 months of enrollment
• History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity
• Received another new chemical entity (defined as a compound which has not been approved for marketing) within 30 days of last Follow-up to first dose of study intervention of this study or 5 half-lives from last dose to first dose of study intervention, whichever is the longest
• Participants who have previously received AZD2693
• Previous enrollment or randomization into the present study