New COPD inhaler spray tested in healthy volunteers – no cure expected
NCT ID NCT07267130
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 2 times
Summary
This early-stage study tests whether a new inhaler spray called TQC3302 is safe and how it moves through the body. It involves 57 healthy adults in China, not people with lung disease. The goal is to check for side effects and measure drug levels, not to treat any condition.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
33 people
The number who actually took part.
- Started
-
Nov 2025
- Finished
-
Aug 2026
- 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: * Subjects voluntarily joined the study, sign informed consent form before the study and fully understand the study content * Healthy subjects aged between 18 and 55 years (inclusive),both male and female * The male subject should weigh at least 50kg, the female subject should weigh at least 45kg. And body mass index (BMI) within 19\~28 kg/m2 * Inhalation administration training qualified. * During the screening period, the percentage of predicted value for forced expiratory volume in one second (FEV1) before bronchodilator administration is ≥80%, and FEV1/forced vital capacity (FVC) is ≥70%. * Have no pregnancy plan and voluntarily take effective contraception measures from time of screening to at least 90 days after the last dose (subjects and their partners) Exclusion Criteria: * Individuals with a history of glaucoma, functional constipation, benign prostatic hyperplasia, urinary tract obstruction, etc * Current history of active tuberculosis, bronchiectasis or other non-specific lung diseases * People who have received or are planning to receive inactive or active vaccines during the 30 days prior to the screening period and the entire study period * Any history of drug allergies, Individuals with a specific history of allergies or allergies * Had undergone surgery within 1 month prior to screening period or expected to undergo surgery during the study period * People with special dietary requirements who cannot follow a standard diet; * People who have potential difficulty in blood collection, or have a history of halo needles or blood sickness; * History of drug or narcotics abuse or a positive result of urine drug test at screening * People who have abnormal and clinically significant results in vital signs, physical examination, laboratory tests, Chest radiograph and abdominal ultrasound during screening period * Subjects Positive for Any of Hepatitis B Virus Surface Antigen (HBsAg), Hepatitis C Virus Antibody (Anti-HCV), Human Immunodeficiency Virus Antibody (Anti-HIV), and Treponema Pallidum Antibody (Anti-TP) * Pregnant or lactating women or those with positive blood pregnancy test results during the screening period
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
China Japan Friendship Hospital Beijing
Beijing, Beijing Municipality, 100000, China
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Other studies related to the condition(s) this trial covers.
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