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

NCT06368440 | Completed Phase 1 FDA Drug

• 1 other identifier: D7860C00003
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of oral AZD6793 in healthy Japanese and Chinese participants.

Conditions

Healthy Participants

Keywords

Chronic obstructive pulmonary disease

Outcome Measures

Primary Outcomes (2)

• Part 1 (SAD): Number of Participants with Adverse Events

  To assess the safety and tolerability of AZD6793 following oral administration of single ascending doses in healthy Japanese participants and a single dose in healthy Chinese participants.

  From Day 1 up to Follow up visit (Day 7±1)

• Part 2 (MAD): Number of Participants with Adverse Events

  To assess the safety and tolerability of AZD6793 following oral administration of multiple doses in healthy Japanese and Chinese participants.

  From Day 1 up to Follow up visit (Day 14±1)

Secondary Outcomes (33)

• Part 1 (SAD) : Maximum Observed Plasma Drug Concentration

  Day 1 to Day 3

• Part 1 (SAD): Time to Reach Peak Concentration (tmax)

  Day 1 to Day 3

• Part 1 (SAD): Terminal Rate Constant, Estimated by Log-Linear Least Squares Regression of the Terminal Part of The Concentration-Time Curve (λz)

  Day 1 to Day 3

• Part 1 (SAD): Half-life Associated with Terminal Slope of a Semi-Logarithmic Concentration-Time Curve (t1/2λz)

  Day 1 to Day 3

• Part 1 (SAD): Partial Area Under the Plasma Concentration Time Curve from Time Zero to Time 12 (AUC[0-12])

  Day 1 to Day 3

Study Arms (5)

Part 1: Cohort 1 AZD6793

EXPERIMENTAL

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; Drug: Placebo

Part 1: Cohort 2 AZD6793

EXPERIMENTAL

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; Drug: Placebo

Part 1: Cohort 3 AZD6793

EXPERIMENTAL

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; Drug: Placebo

Part 2: Cohort 1 AZD6793

EXPERIMENTAL

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; Drug: Placebo

Part 2: Cohort 2 AZD6793

EXPERIMENTAL

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; Drug: Placebo

Interventions

AZD6793 DRUG

Participants will receive AZD6793 single dose as oral suspension.

Part 1: Cohort 1 AZD6793; Part 1: Cohort 2 AZD6793; Part 1: Cohort 3 AZD6793

Placebo DRUG

Participants will receive matching doses of placebo as oral suspension.

Part 1: Cohort 1 AZD6793; Part 1: Cohort 2 AZD6793; Part 1: Cohort 3 AZD6793; Part 2: Cohort 1 AZD6793; Part 2: Cohort 2 AZD6793

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \. 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.
• \. Diagnosis or history of immunodeficiency or increased susceptibility to severe infection, or a clinically significant infection within 4 weeks of the Screening Visit.
• \. Any positive result on screening for serum hepatitis B surface antigen, hepatitis B core antibody, or human immunodeficiency virus.
• \. 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.
• \. 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.
• \. 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.
• \. Known or suspected history of alcohol or drug abuse or excessive intake of alcohol as judged by the Investigator.
• \. Positive screen for drugs of abuse, or alcohol or cotinine at the Screening Visit or admission to the Clinical Unit (Day -1).
• \. 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).
• \. Use of drugs with enzyme inducing properties such as St John's Wort within 3 weeks prior to the first administration of study intervention.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Glendale, California, 91206, United States

Location

Related Links

• D7860C00003\_CSR Synopsis\_Redacted

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 16, 2024
• Study Start: May 15, 2024
• Primary Completion: December 23, 2024
• Study Completion: December 23, 2024
• Last Updated: October 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA 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 anonymized individual patient-level data via secure researchenvironmentVivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

US (1)