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

NCT05107336 | Completed Phase 1

• 1 other identifier: D7830C00006
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Participants

Keywords

Pharmacokinetics; Healthy Japanese Participants; Non-alcoholic fatty liver disease; Non-alcoholic steatohepatitis

Outcome Measures

Primary Outcomes (1)

• Number 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 participants will be evaluated.

  Until Day 162 (Final/Early termination visit)

Secondary Outcomes (28)

• Maximum observed plasma drug concentration (Cmax) of AZD2693

  Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)

• Time to reach peak or maximum observed concentration following drug administration (tmax) of AZD2693

  Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)

• Terminal elimination rate constant, estimated by log-linear least-squares regression of the terminal part of the concentration-time curve (λz) of AZD2693

  Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)

• Apparent terminal elimination half-life associated with the terminal slope (λz) of the semi-logarithmic concentration-time curve (t½λz) of AZD2693

  Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)

• Area under the plasma concentration-time curve from time zero to 48 hours after dosing AUC (0-48) of AZD2693

  Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)

Study Arms (5)

Cohort 1: AZD2693

EXPERIMENTAL

Japanese Participants will receive Dose A of AZD2693.

Drug: AZD2693

Cohort 2: AZD2693

EXPERIMENTAL

Japanese Participants will receive Dose B of AZD2693.

Drug: AZD2693

Cohort 3: AZD2693

EXPERIMENTAL

Japanese Participants will receive Dose C of AZD2693.

Drug: AZD2693

Cohort 4: AZD2693

EXPERIMENTAL

Non-Asian Participants will receive Dose C of AZD2693

Drug: AZD2693

Placebo

PLACEBO COMPARATOR

Japanese and Non-Asian Participants will receive placebo matching Dose A, B, and C to AZD2693.

Drug: Placebo

Interventions

AZD2693 DRUG

Participants will receive subcutaneous injection of AZD2693, once per month.

Cohort 1: AZD2693; Cohort 2: AZD2693; Cohort 3: AZD2693; Cohort 4: AZD2693

Placebo DRUG

Participants will receive subcutaneous injection of placebo (volume matching to AZD2693 injection \[0.9% saline solution\]), once per month.

Placebo

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Sumida-ku, 130-0004, Japan

Location

Related Links

• Redacted CSR synopsis.

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The study center staff including the Investigator have to remain blinded during the clinical conduct of a given cohort with regard to study intervention (AZD2693 or placebo). The study will be blinded for all study personnel including the Investigator during the clinical conduct of the study and the Sponsor will remain blinded up to the unblinded safety review committee review of the data from the study
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 4, 2021
• Study Start: November 25, 2021
• Primary Completion: March 21, 2023
• Study Completion: March 21, 2023
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at: https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patientlevel data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at: https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure.

Locations

JP (1)