Study to Assess the Safety, Tolerability, and Pharmacokinetics (movement of drugs within the body) of AZD2693 in Healthy Participants

Study identifier:D7830C00006

ClinicalTrials.gov identifier:NCT05107336

EudraCT identifier:N/A

CTIS identifier:N/A

Recruitment Complete

Official Title

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 Participants

Medical condition

Healthy Participants

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD2693, Placebo

Sex

All

Actual Enrollment

Study type

Interventional

Age

20 Years - 60 Years

Date

Study Start Date: 25 Nov 2021

Estimated Primary Completion Date: 21 Mar 2023

Estimated Study Completion Date: 21 Mar 2023

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Other

Verification:

Verified 01 Jan 2023 by AstraZeneca

Collaborators

Inclusion and exclusion 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

No locations available

Arms	Assigned Interventions
Experimental: Cohort 1: AZD2693 Japanese Participants will receive Dose A of AZD2693.	Drug: AZD2693 Participants will receive subcutaneous injection of AZD2693, once per month.
Experimental: Cohort 2: AZD2693 Japanese Participants will receive Dose B of AZD2693.	Drug: AZD2693 Participants will receive subcutaneous injection of AZD2693, once per month.
Experimental: Cohort 3: AZD2693 Japanese Participants will receive Dose C of AZD2693.	Drug: AZD2693 Participants will receive subcutaneous injection of AZD2693, once per month.
Experimental: Cohort 4: AZD2693 Non-Asian Participants will receive Dose C of AZD2693	Drug: AZD2693 Participants will receive subcutaneous injection of AZD2693, once per month.
Placebo Comparator: Placebo Japanese and Non-Asian Participants will receive placebo matching Dose A, B, and C to AZD2693.	Drug: Placebo Participants will receive subcutaneous injection of placebo (volume matching to AZD2693 injection [0.9% saline solution]), once per month.

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]