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 Japanese Participants
- Conditions
- nonalcoholic fatty liver disease
- Registration Number
- JPRN-jRCT2071210096
- Lead Sponsor
- Hibi Kazushige
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 22
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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)<br>Safety and tolerability of AZD2693 compared to placebo following multiple dose SC administration in healthy Japanese participants will be evaluated.
- Secondary Outcome Measures
Name Time Method