nonalcoholic fatty liver disease
Conditions
Interventions
Each participant is expected to be in the study for approximately 23 weeks, including a Screening Period of up to 4 weeks, a 9 week Treatment Period, and a Follow up Period of 10 weeks. Participants w
Sponsors
Ageishi Yuji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Participants must be 18 to 60 years of age inclusive, at the time of signing the informed consent. 2 Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. 3 Participants who are of Japanese ethnicity A Japanese participant is defined as having both parents and 4 grandparents who are ethnically Japanese. This includes second and third generation Japanese whose parents or grandparents are living in a country other than Japan. 4 Participants must have suitable veins for cannulation or repeated venepuncture. 5 Body mass index within the range 18 to 32 kg/m2 (inclusive) and weigh at least 50 kg. 6 Males and/or females Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Exclusion criteria
Exclusion criteria: 1 As judged by the investigator, any evidence of any clinically important disease or disorder which, in the investigator's opinion makes it undesirable for the participant to participate in the study. 2 History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs. 3 Participants with known autoimmune disease or on-treatment with immune modulatory drugs. 4 Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of study intervention. 5 Any clinically significant cardiovascular event within last 6 months prior to the Screening Visit. 6 Any clinically important abnormalities in clinical chemistry, haematology or urinalysis results, including participants with platelet or bleeding disorders, and known platelet dysfunction disorders as judged by the investigator. 7 Any positive result at the Screening Visit for serum HBsAg, hepatitis C antibody and HIV. 8 Confirmed COVID-19 infection during screening as per local guidelines. 9 Abnormal vital signs, after 10 minutes supine rest at the Screening Visit and/or Day-1 20 Participation in another clinical study with a study intervention administered in the last 3 months prior to randomisation. 27 Previous randomisation in the present study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the safety and tolerability of AZD7503 following SC administration of multiple doses in healthy Japanese participants. - AEs and SAEs - 12-lead safety ECGs, dECGs, and telemetry - Vital signs (including BP, pulse rate, and body temperature) - Physical examination - ISRs - Clinical laboratory evaluations (haematology, including platelet count, clinical chemistry, and coagulation, renal safety biomarkers, immune activation response, complement activation panel, and urinalysis). | — |
Contacts
Public ContactYuji Ageishi
Astrazeneka K.K
Outcome results
None listed