NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of AZD7503 in Japanese Healthy Participants.
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of AZD7503 in Japanese Healthy Participants.
CompletedPhase 1
Sponsor: AstraZeneca
Conditions: Heathy Participants
Interventions: AZD7053, Placebo
Countries: Japan
The study will evaluate the safety, tolerability, and the pharmacokinetics (PK) of AZD7503 following multiple subcutaneous doses in healthy Japanese participants.
Eligibility overview
Sex: ALL
Age: 18 Years to 60 Years
Healthy volunteers: Yes
Study type: INTERVENTIONAL
Eligibility criteria
Inclusion Criteria: * For Japanese participants: A Japanese participant is defined as having both parents and 4 Japanese grandparents as confirmed by the interview. This includes second and third generation Japanese whose parents or grandparents are living in a country other than Japan. Participants must have suitable veins for cannulation. * Females must be of non-childbearing potential. * Males and females must adhere to the contraception methods. * Have a Body mass index between 18 and 30 kg/m2 inclusive. Exclusion Criteria: * History of any clinically significant disease or disorder in the investigator's opinion. * History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs. * Any clinically important illness, medical/surgical procedure or trauma. * Any abnormal laboratory values, clinical chemistry, hematology or urinalysis results, vital signs, Electrocardiography. * Any clinically significant cardiovascular event. * Participants with known autoimmune disease or on-treatment with immune-modulatory drugs. * Any positive result at the Screening Visit for serum Hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency virus. * Confirmed COVID-19 infection during screening as per local guidelines. * History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity. * Use of any prescribed or nonprescribed medication. * History of major bleed or high-risk of bleeding diathesis. * Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of study intervention. * Participants who have previously received AZD7503 or any investigational drug targeting HSD17B13. * Vulnerable participants.
Locations (1)
- Sumida-ku, Japan