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New inhaled drug passes first safety check in small human study

NCT ID NCT07439419

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.