A Study to Investigate the Safety and Pharmacokinetics of AZD6793 in Healthy Japanese and Chinese Participants

Study identifier:D7860C00003

ClinicalTrials.gov identifier:NCT06368440

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Single-blind, Randomized, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of an oral suspension of AZD6793 Following Single and Multiple Doses in Japanese and Chinese Healthy Participants

Medical condition

Healthy Participants

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD6793, Placebo

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 15 May 2024

Primary Completion Date: 23 Dec 2024

Study Completion Date: 23 Dec 2024

Study design

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

Verification:

Verified 01 Dec 2024 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

1. For Japanese participants only:
(a) Participant was born in Japan
(b) Participant has 2 Japanese biological parents and 4 Japanese grandparents as confirmed by the interview.
(c) Participant did not live outside of Japan for more than 10 years at the time of the Screening Visit.
2. For Chinese participants only:
(a) Participant was born in China (including Hong Kong, Macau, and Taiwan)
(b) Participant has 2 Chinese biological parents and 4 Chinese grandparents as confirmed by the interview.
(c) Participant did not live outside of greater China for more than 10 years at the time of the Screening Visit.
3. All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
4. Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception,
5. Have a body mass index between 18 and 30 kilograms per meter square (kg/m2) inclusive and weigh at least 45 kilograms (kg), at the Screening Visit.
6. Females of non-childbearing potential must be
confirmed at the screening Visit by fulfilling one of the following criteria:
(a) Postmenopausal defined as amenorrhea for at least 12 months following cessation of all exogenous hormonal treatments and FSH levels in the postmenopausal range.
(b) Documentation of irreversible surgical sterilization by hysterectomy, bilateral
oophorectomy, or bilateral salpingectomy (but not tubal ligation).
Main

Exclusion Criteria

1. History of any clinically important disease or disorder or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
3. Diagnosis or history of immunodeficiency or increased susceptibility to severe infection, or a clinically significant infection within 4 weeks of the Screening Visit.
4. Any positive result on screening for serum hepatitis B surface antigen, hepatitis B core antibody, or human immunodeficiency virus.
5. History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD6793.
6. Plasma donation within one month of the Screening Visit or any blood donation/blood loss greater than (>) 500 milliliter (mL) during the 3 months prior to the Screening Visit.
7. Participants who have previously received AZD6793.
8. Positive or indeterminate QuantiFERON® TB test at Screening Visit.
9. Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the previous 3 months prior to the Screening Visit.
10. Known or suspected history of alcohol or drug abuse or excessive intake of alcohol as judged by the Investigator.
11. Positive screen for drugs of abuse, or alcohol or cotinine at the Screening Visit or admission to the Clinical Unit (Day -1).
12. Excessive intake of caffeine-containing drinks or food (eg, coffee, tea, chocolate) defined as the regular consumption of more than 500 mg of caffeine per day (eg, > 5 cups of coffee [one cup ~100 mg caffeine]; one cup of tea ~30 mg caffeine).
13. Use of drugs with enzyme inducing properties such as St John’s Wort within 3 weeks prior to the first administration of study intervention.

No locations available

Arms	Assigned Interventions
Experimental: Part 1: Cohort 1 AZD6793 6 Healthy Japanese participants will receive single dose of AZD6793 dose 1 and 2 healthy Japanese participants will receive matching placebo to AZD6793 as oral suspension on Day 1.	Drug: AZD6793 Participants will receive AZD6793 single dose as oral suspension. Drug: Placebo Participants will receive matching doses of placebo as oral suspension.
Experimental: Part 1: Cohort 2 AZD6793 6 Healthy Japanese participants will receive single dose of AZD6793 dose 2 and 2 healthy Japanese participants will receive matching placebo to AZD6793 as oral suspension on Day 1.	Drug: AZD6793 Participants will receive AZD6793 single dose as oral suspension. Drug: Placebo Participants will receive matching doses of placebo as oral suspension.
Experimental: Part 1: Cohort 3 AZD6793 6 Healthy Chinese participants will receive single dose of AZD6793 dose 1 and 2 healthy Chinese participants will receive matching placebo to AZD6793 as oral suspension on Day 1.	Drug: AZD6793 Participants will receive AZD6793 single dose as oral suspension. Drug: Placebo Participants will receive matching doses of placebo as oral suspension.
Experimental: Part 2: Cohort 1 AZD6793 6 Japanese participants will receive single dose of AZD6793 and 2 participants will receive matching placebo on Day 1. After a washout of at least 48 hours, participants will receive AZD6793 or placebo once daily from Day 3 to Day 8.	Drug: AZD6793 Participants will receive AZD6793 multiple doses daily as oral suspension. Drug: Placebo Participants will receive matching doses of placebo as oral suspension.
Experimental: Part 2: Cohort 2 AZD6793 6 Chinese participants will receive single dose of AZD6793 and 2 participants will receive matching placebo on Day 1. After a washout of at least 48 hours, participants will receive AZD6793 or placebo once daily from Day 3 to Day 8.	Drug: AZD6793 Participants will receive AZD6793 multiple doses daily as oral suspension. Drug: Placebo Participants will receive matching doses of placebo as oral suspension.

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]