A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of AZD7503 in Japanese Heal… (NCT06093542) | Clinical Trial Compass
CompletedPhase 1
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of AZD7503 in Japanese Healthy Participants.
Japan12 participantsStarted 2023-10-25
Plain-language summary
The study will evaluate the safety, tolerability, and the pharmacokinetics (PK) of AZD7503 following multiple subcutaneous doses in healthy Japanese participants.
Who can participate
Age range18 Years – 60 Years
SexALL
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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 m…
What they're measuring
1
Number of participants with adverse events
Timeframe: From Screening (Day -28) until Follow-up Day 127 (10 weeks post last dose)