A study to investigate safety, tolerability, and pharmacokinetics of AZD7503 in healthy Japanese participants.
- Conditions
- nonalcoholic fatty liver disease
- Registration Number
- JPRN-jRCT2071230075
- Lead Sponsor
- Ageishi Yuji
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 12
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method