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New asthma inhaler passes first safety check in small study

NCT ID NCT06385964

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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-stage trial tested an experimental drug called SHR-4597, given as an inhaled powder, in 62 healthy volunteers and people with asthma. The main goal was to see if it is safe and tolerable. The study gave single doses to healthy people and multiple doses over several days to asthma patients with mild to severe symptoms. This is a first step to see if the drug is safe enough for further testing.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SHR-4597 (an experimental drug taken by inhaling a dry powder)
What this could lead to
If safe, this could lead to a new inhaled treatment option for asthma that helps control symptoms.
What could go wrong
This is a very early Phase 1 trial focused only on safety, not on whether the drug works. It is small (62 people) and may not lead to an effective treatment.

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

62 people

The number who actually took part.

Started

May 2024

Finished

Feb 2025

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 75 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: \- Healthy subjects: * Understand the specific procedures of the trial, voluntarily participate in this trial, and sign the informed consent form in writing. * Aged between 18 and 55 years old (inclusive of boundary values). * Male subjects with a weight of ≥ 50 kg and female subjects with a weight of ≥ 45 kg, with a body mass index (BMI) between 18 and 30 kg/m2 (inclusive of boundary values). * Vital signs, physical examinations, laboratory tests, chest X-rays, etc., are either normal or clinically insignificant in abnormalities. * Female subjects of reproductive potential or male subjects whose partners are of reproductive potential must agree, from the time of signing the informed consent form until 1 month after the last dose of study drug administration, to have no plans for pregnancy and voluntarily adopt effective contraception measures (including partners), while also avoiding sperm/egg donation (see Appendix 1 for details). * During the study period, participants must be able to comply with all study regulations and procedures and be able to use the inhalation device used in this study correctly. Asthma patients: * Age ≥ 18 years and ≤ 75 years, gender not specified. * Body Mass Index (BMI) during screening period ≥ 18 and ≤ 30 kg/m2. * History records and objective evidence of asthma diagnosis meeting current guidelines in the 12 months prior to randomization. * Not received any asthma treatment or only used short-acting bronchodilators (SABA) on an as-needed basis in the 4 weeks prior to randomization; or received maintenance therapy with medium to high daily doses of inhaled corticosteroids (ICS) and/or other asthma control medications for at least 3 months prior to randomization, and the dosage regimen and asthma condition remained stable in the 4 weeks prior to randomization. * FEV1 ≥ 60% or ≥40% and \< 80% of predicted value before inhalation bronchodilator use during screening and baseline. * FeNO value ≥ 25 ppb during screening and baseline. * Female subjects of reproductive potential or male subjects whose partners are of reproductive potential must agree, from the time of signing the informed consent form until 1 month after the last dose of study drug administration, to have no plans for pregnancy and voluntarily adopt effective contraception measures (including partners), while also avoiding sperm/egg donation (see Appendix 1 for details). * Voluntarily sign the informed consent form to participate in this study. Exclusion Criteria: \- Healthy subjects: * Suffering from any clinically serious disease such as circulatory, endocrine, nervous, digestive, respiratory, hematological, immunological, psychiatric and metabolic abnormalities, or any other disease that might interfere with the study results; * Previous history of malignant tumor; * Current or recent (within 3 months) respiratory disease or a history of severe respiratory disease, and researchers assess that it may affect drug absorption or pose a safety risk; * Patients with severe infection, severe trauma or major surgical operation within 3 months before administration; Patients who plan to undergo surgery during the trial period and within two weeks of its end; * 12-lead ECG abnormalities are clinically significant or ECG QT interval (QTc) \> 450 ms in male subjects and ECG QTc \> 470 ms in female subjects; * Screening for infectious diseases during the screening period, including positive results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody, human immunodeficiency virus antibody, and syphilis treponema antibody; * People with a suspected history of allergy to the investigational drug or any of the ingredients in the investigational drug, allergies or a history of severe drug allergy; * Previous blood collection difficulties or can not tolerate venipuncture, such as fainting needle, fainting blood * Had taken any prescription, over-the-counter, or Chinese herbal medicine within 14 days prior to taking the study drug, or within 5 half-lives of the drug at the time of screening; Plan to take non-study medications during the trial period.; * Participants who have participated in clinical trials of any drug or medical device within 3 months prior to screening, or those still within 5 half-lives of a drug prior to screening (whichever is longer); * Blood donation or blood loss ≥ 200 mL within 1 month prior to administration, or blood donation or blood loss ≥ 400 mL within 3 months prior to administration, or received blood transfusion within 8 weeks; * Average smoking ≥ 5 cigarettes per day in the three months prior to administration; More than 15 g of alcohol per day on average in the month prior to administration (15 g of alcohol is equivalent to 450 mL of beer or 150 mL of wine or 50 mL of low-alcohol liquor); * People who do not refrain from smoking, drinking or consuming caffeinated food or beverages (more than 8 cups, 1 cup = 250 mL) 2 days before administration and during the trial period; Those who cannot prohibit the consumption of grapefruit or grapefruit juice; And those who have special requirements for diet and cannot comply with a unified diet; * Subjects who are pregnant (tested positive during screening or baseline pregnancy test) or who plan to become pregnant while breastfeeding or during the study; * Participants with positive drug screening or alcohol breath test during screening visit/baseline visit; * Other conditions deemed by the investigator as unsuitable for participation in this trial; Asthma patients: * Combined with clinically significant lung diseases, including but not limited to active pulmonary tuberculosis, bronchiectasis, atelectasis, idiopathic pulmonary fibrosis, bronchopulmonary aspergillosis, and chronic obstructive pulmonary disease (COPD); * Malignant tumors diagnosed within 5 years prior to randomization (Excluding malignancies with low risk of metastasis and death, such as adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix); * Combined with poorly controlled hypertension (systolic blood pressure ≥180mmHg, and/or diastolic blood pressure ≥110mmHg during screening) or uncontrolled severe cardiovascular and cerebrovascular disease; * Known immunodeficiency; * A history of infections requiring clinical intervention within 4 weeks prior to randomization, including but not limited to respiratory infections: * Known parasitic infection within 6 months prior to randomization; * Receiving a non-selective beta-blocker (e.g., propranolol) within 1 week prior to randomization; * Blood donation or significant blood loss (≥400ml), or transfusion of blood products or immunoglobulin within 4 weeks prior to randomization; * Received attenuated live vaccines within 4 weeks prior to randomization; * Allergen immunotherapy was administered 8 weeks before randomization * Used systemic immunosuppressive agents (including systemic corticosteroids for asthma treatment, and other systemic corticosteroids \<3 days for conditions other than asthma), or immunomodulators, or biologics or Th2 cell cytokine inhibitors within 12 weeks prior to randomization or within 5 half-lives of the drug (whichever is longer, with reference to the drug's prescribing information; for drugs with unknown half-life, the 12 weeks prior to randomization is considered; * Bronchial thermoplasty was performed within 1 year prior to randomization * Planned surgical procedures during the study period, or other therapeutic measures deemed by the investigator to potentially affect the assessment of the subjects; * The screening period or baseline laboratory tests showed significant abnormalities * Prolonged ECG QTc interval (men \>450ms, women \>470ms) or other clinically significant abnormal results that may pose a significant safety risk to subjects during the screening period * Screening period is still smoking or quit smoking less than 6 months, or previous smoking ≥10 pack years (pack years = number of years of smoking × number of packs per day) * A history of drug use, alcohol abuse (average consumption of ≥14 units of alcohol per week: 1 unit = 285 mL for beer, or 25 mL for spirits, or 100 ml for wine) or drug abuse within 1 year prior to screening * Participated in another clinical study and used investigational drugs containing active ingredients within 30 days prior to screening, or still within 5 half-lives of the investigational drug at the time of screening (whichever is longer). * Subjects who are pregnant (screening or baseline blood pregnancy test positive) or who plan to become pregnant while breastfeeding or during the study * People who are allergic to the drug or its excipients, allergic or have a history of severe drug allergy * Other reasons deemed by the investigator as unsuitable for participation in the study

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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

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 200433, China

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