New inhaled drug tested in healthy volunteers – no treatment expected
NCT ID NCT06519968
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage study tested the safety and how the body handles an inhaled drug called AZD4604 in 56 healthy Japanese and Chinese adults. Participants received either the drug or a placebo as a dry powder inhaler. The goal was only to check for side effects and measure drug levels in the blood, not to treat any disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AZD4604 (inhaled dry powder)
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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56 people
The number who actually took part.
- Started
-
Jul 2024
- Finished
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Dec 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Japanese participants who are born in Japan, has 2 Japanese biological parents, 4 Japanese grandparents as confirmed by the interview and has lived outside Japan for less than 10 years at the time of screening. * Chinese participants who are born in China, has 2 Chinese biological parents, 4 Chinese grandparents as confirmed by the interview and has lived outside China for less than 10 years at the time of screening. * Have body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 45 kg. * Healthy participants must have a Forced Expiratory Volume at first breath (FEV1) ≥ 80% of the predicted value in accordance with American Thoracic Society (ATS)/European Respiratory Society (ERS) criteria at the Screening and admission visits. * Female participants must have a negative pregnancy test. Exclusion Criteria: * History or presence of clinically important disease which may put participant at risk because of participation in study. * Participant has an increased risk of infection. * History of malignancy other than superficial basal cell carcinoma, having a first degree relative with lung cancer or disease history suggesting abnormal immune function. * Has received any vaccine 30 days prior to first dose. * Has a body temperature of \> 37.7°C on Day -1. * History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs. * Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention. * Known or suspected history of drug abuse, alcohol abuse or excessive intake of alcohol. * Current smokers or those who have smoked or used nicotine products (including e-cigarettes, vaping, and nicotine replacement therapy) within the previous 6 months or has a smoking history of \> 5 pack-years. * History of a serious or severe adverse reaction to AZD4604 or any of its additive constituents. * 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 AZD4604. * Plasma donation within 1 month of the Screening Visit or any blood donation/blood loss\> 500 mL during the 3 months prior to the Screening Visit. * Any clinically important abnormalities in rhythm, conduction or morphology of the resting electrocardiogram (ECG) and any clinically important abnormalities in the 12-lead safety ECG. * Female participants who are planning a pregnancy during the study period or within 1 month after the last dose of study intervention. * Abnormal vital signs at the Screening Visit, after 5 minutes supine rest. * History of any significant respiratory disorders such as asthma (a history of childhood asthma without symptoms or treatment after the age of 10 years is allowable), chronic obstructive pulmonary disease, or idiopathic pulmonary fibrosis.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Research Site
Harrow, HA1 3UJ, United Kingdom
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