A study to investigate the safety, tolerability, and pharmacokinetics (PK) of oral AZD6793 in healthy subjects

Study identifier:D7860C00001

ClinicalTrials.gov identifier:NCT05662033

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

Official Title

A Single blind, Randomised, Placebo controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of oral AZD6793 Following Single and Multiple Ascending Doses in Healthy Subjects

Medical condition

Inflammatory diseases

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD6793, Placebo

Sex

All

Estimated Enrollment

133

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 05 Dec 2022

Estimated Primary Completion Date: 22 Aug 2023

Estimated Study Completion Date: 22 Aug 2023

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Feb 2023 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

- Healthy male or female subjects aged 18 to 55 years with suitable veins for cannulation or repeated venepuncture
- Females must have a negative pregnancy test must not be lactating and must be either (a) non-childbearing potential, confirmed by post-menopausal defined as amenorrhea for at least 12 months; documentation of irreversible surgical sterilisation or (b) childbearing potential, i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile (Must agree to use, with their partner, an approved method of highly effective contraception).
- Male subjects and their female partners of childbearing potential must be willing to use highly effective contraception measures and male subjects must refrain from donating sperm or fathering a child from the first day of dosing until 3 months after the last dose of IMP.
-Have a BMI between 18 and 30 kg/m2 inclusive and weigh at least 50 kg, at the Screening Visit.

Exclusion Criteria

- History or presence of gastrointestinal, hepatic, renal, pancreatic disease or acute disease in these organs.
-History of chronic haematologic disease.
-Diagnosis or history of immunodeficiency or increased susceptibility to severe infection, or a clinically significant infection
-Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP.
-Positive or indeterminate QuantiFERON® Tuberculosis (TB) test at screening.
-Any clinically important abnormalities in clinical chemistry, haematology or urinalysis results
-Any positive result on Screening for serum Hepatitis B surface antigen (HBsAg), hepatitis C antibody and Human immunodeficiency virus (HIV).
-Any clinically important abnormalities in rhythm, conduction or morphology of the resting Electrocardiogram (ECG) and any clinically important abnormalities in the 12 lead ECG.
-Known or suspected history of alcohol and drug abuse in the last year.
-Current smokers or those who have smoked or used nicotine products (including e cigarettes) within the previous 3 months.
-History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, or history of hypersensitivity to drugs with a similar chemical structure or class to AZD6793.
-Excessive intake of caffeine containing drinks or food
-Use of drugs with enzyme inducing properties such as St John’s Wort within 3 weeks prior to the first administration of IMP.
-Use of any prescribed or nonprescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, mega dose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to the first administration of IMP or longer if the medication has a long half life
-Plasma donation within one month of the Screening Visit or any blood donation/blood loss > 500 mL during the 3 months prior to the Screening Visit.
-Part 2 only: Subjects who have previously received AZD6793.

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Arms	Assigned Interventions
Experimental: Part 1 (SAD): Cohort 1 6 Healthy subjects will receive a single oral dose A of AZD6793 and 2 healthy subjects will receive placebo	Drug: AZD6793 AZD6793 will be administered orally Drug: Placebo Placebo will be administered orally
Experimental: Part 1 (SAD): Cohort 2 6 Healthy subjects will receive a single oral dose B of AZD6793 and 2 healthy subjects will receive placebo	Drug: AZD6793 AZD6793 will be administered orally Drug: Placebo Placebo will be administered orally
Experimental: Part 1 (SAD): Cohort 3 6 Healthy subjects will receive a single oral dose C of AZD6793 and 2 healthy subjects will receive placebo	Drug: AZD6793 AZD6793 will be administered orally Drug: Placebo Placebo will be administered orally
Experimental: Part 1 (SAD): Cohort 4 6 Healthy subjects will receive a single oral dose D of AZD6793 and 2 healthy subjects will receive placebo	Drug: AZD6793 AZD6793 will be administered orally Drug: Placebo Placebo will be administered orally
Experimental: Part 1 (SAD): Cohort 5 6 Healthy subjects will receive a single oral dose E of AZD6793 and 2 healthy subjects will receive placebo	Drug: AZD6793 AZD6793 will be administered orally Drug: Placebo Placebo will be administered orally
Experimental: Part 2 (MAD): Cohort 1 6 Healthy subjects will receive dose X of AZD6793 and 2 healthy subjects will receive placebo once daily on Day 1 and 8 and twice daily on Day 3 to Day 7	Drug: AZD6793 AZD6793 will be administered orally Drug: Placebo Placebo will be administered orally
Experimental: Part 2 (MAD): Cohort 2 6 Healthy subjects will receive dose Y of AZD6793 and 2 healthy subjects will receive placebo once daily on Day 1 and 8 and twice daily on Day 3 to Day 7	Drug: AZD6793 AZD6793 will be administered orally Drug: Placebo Placebo will be administered orally
Experimental: Part 2 (MAD): Cohort 3 6 Healthy subjects will receive dose Z of AZD6793 and 2 healthy subjects will receive placebo once daily on Day 1 and 8 and twice daily on Day 3 to Day 7	Drug: AZD6793 AZD6793 will be administered orally Drug: Placebo Placebo will be administered orally

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]