NCT06368440CompletedPhase 1
A Study to Investigate the Safety and Pharmacokinetics of AZD6793 in Healthy Japanese and Chinese Participants
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
Source: ClinicalTrials.gov · Last updated 24 Oct 2025
Brief summary (registry, in English)
The main purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of oral AZD6793 in healthy Japanese and Chinese participants.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 39 (actual)
- First submitted
- 11 Apr 2024
- Start date
- 15 May 2024
- Primary completion date
- 23 Dec 2024
- Lead sponsor
- AstraZeneca
- Diseases
- COPD
- NCT number
- NCT06368440
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 39
- From 15 May 2024 to the primary completion date, 23 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Main Inclusion Criteria:
- 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).
- 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.
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Glendale | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.