NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2071210096

Registered date:24/11/2021

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

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiednonalcoholic fatty liver disease
Date of first enrollment13/09/2021
Target sample size22
Countries of recruitment
Study typeInterventional
Intervention(s)Drug: AZD2693 Participants will receive subcutaneous injection of AZD2693, once per month. Drug: Placebo Participants will receive subcutaneous injection of placebo, once per month.

Outcome(s)

Primary OutcomeNumber of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Safety and tolerability of AZD2693 compared to placebo following multiple dose SC administration in healthy Japanese participants will be evaluated.
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 60age old
GenderBoth
Include criteria- 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
Exclude criteria- 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

Related Information

Contact

Public contact
Name Kazushige Hibi
Address 3-1, Ofuka-cho, Kita-ku, Osaka-shi Osaka Japan 530-0011
Telephone +81-6-4802-3533
E-mail RD-clinical-information-Japan@astrazeneca.com
Affiliation Astrazeneka K.K
Scientific contact
Name Kazushige Hibi
Address 3-1, Ofuka-cho, Kita-ku, Osaka-shi Osaka Japan 530-0011
Telephone +81-6-4802-3533
E-mail RD-clinical-information-Japan@astrazeneca.com
Affiliation Astrazeneka K.K