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Study to Assess the Safety, Tolerability, and Pharmacokinetics (Movement of Drugs Within the Body) of AZD2693 in Healthy Participants
Study to Assess the Safety, Tolerability, and Pharmacokinetics (Movement of Drugs Within the Body) of AZD2693 in Healthy Participants

NCT05107336

CompletedPhase 1

Sponsor: AstraZeneca

Conditions: Healthy Participants

Interventions: AZD2693, Placebo

Countries: Japan

This Phase I, randomised, single-blind, placebo-controlled study has been designed to assess the safety, tolerability, and pharmacokinetics (PK) of AZD2693 following subcutaneous (SC) administration of AZD2693 in healthy participants

Eligibility overview

Sex: ALL

Age: 20 Years to 60 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion 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

Exclusion 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
Locations (1)
  • Sumida-ku, Japan