New inhaled drug passes first safety check in small human study
NCT ID NCT07439419
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tested the safety and tolerability of an inhaled drug called DBM-1152A in 20 healthy Chinese adults. Participants received either the drug or a placebo once daily for 7 days at different dose levels. The study focused on side effects and how the drug moves through the body, not on treating 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
- DBM-1152A inhalation solution
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
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
20 people
The number who actually took part.
- Started
-
Aug 2024
- Finished
-
Oct 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 45 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: 1. Healthy male or female subjects. 2. Aged 18 to 45 years (inclusive) at screening. 3. Body weight: Male ≥ 50.0 kg, Female ≥ 45.0 kg; Body Mass Index (BMI): 19.0 - 28.0 kg/m² (inclusive). 4. Capable of understanding and providing written informed consent. 5. Able and willing to adhere to the study protocol. Exclusion Criteria: 1. Clinically significant abnormalities in screening assessments (physical exam, vital signs, labs, chest X-ray, ophthalmology). 2. Pulmonary function: FEV1/FVC \< 80% at screening. 3. Positive serology for HBsAg, HCV, HIV, or TP-Ab. 4. Clinically significant 12-lead ECG abnormalities or QTcF \> 450 ms (male) / \> 470 ms (female). 5. Acute or chronic oral/pharyngeal disease. 6. History or presence of significant chronic diseases of any major organ system. 7. History of specific diseases (glaucoma, constipation, BPH, urinary obstruction, epilepsy, hyperthyroidism, etc.). 8. History of short or long QT syndrome. 9. Respiratory infection within 6 weeks (lower) or 2 weeks (upper) prior to screening. 10. Major surgery within 3 months prior to screening or planned during study. 11. Hypersensitivity to study drug components or related drugs. 12. History or evidence of drug abuse or positive drug screen. 13. Excessive daily intake of tea, coffee, or caffeine (\>8 cups) within 3 months prior to screening. 14. Inability to refrain from certain foods/beverages containing caffeine/xanthine/glucose. 15. Excessive alcohol consumption or positive alcohol screen. 16. Smoking ≥5 cigarettes per day within 3 months prior to screening or positive nicotine test. 17. Use of any drugs (including herbs/vitamins) within 30 days prior to screening. 18. Participation in another clinical trial within 3 months prior to screening. 19. Blood donation/loss (\>400 mL) within 3 months prior to screening or planned during/after study. 20. Difficulty with venipuncture or intolerance to intravenous access. 21. History of needle or blood phobia. 22. Intolerance to inhaled administration. 23. Pregnancy, lactation, or positive pregnancy test. 24. Unwillingness to use effective contraception during and for 6 months after the study. 25. Special dietary requirements or inability to comply with standardized diet. 26. Poor compliance as judged by the investigator. 27. Any other condition considered unsuitable for participation by the investigator.
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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
-
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
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