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Healthy SubjectsPhase 1NCT06385964

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SHR-4597 Inhalation in Healthy Subjects and Asthmatic Patients

A Phase 1 study testing SHR-4597 in people with Healthy Subjects and Asthmatic Patients, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of this randomized, double-blind, single/multiple ascending dose, placebo-controlled Phase I clinical trial was to evaluate the safety and tolerability of SHR-4597 in healthy subjects and asthmatic patients. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Subjects, Asthmatic Patients
What is being tested?
SHR-4597
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
62 participants
Where
1 siteChina
Study dates
7 May 2024to 19 Feb 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • -
  • 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.
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  • 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.

Who cannot join

  • -
  • 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;
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  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 200433

Other trials in China

About this study

Official title: A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Dose of SHR-4597 Inhalation in Healthy Subjects and Asthmatic Patients

The primary objective of this randomized, double-blind, single/multiple ascending dose, placebo-controlled Phase I clinical trial was to evaluate the safety and tolerability of SHR-4597 in healthy subjects and asthmatic patients. The study consists of two parts: Part 1 involves single ascending inhalation dose in healthy subjects; Part 2 involves multiple ascending inhalation dose in asthmatic patients, further divided into Part 2A: multiple ascending inhalation dose in mild to moderate asthmatic patients, and Part 2B: multiple ascending inhalation dose in moderate to severe asthmatic patients. Subsequent lung pharmacokinetic studies of SHR-4597 inhalation will be conducted based on patients' PKPD data.

Being tested
SHR-4597, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR-4597Drug

    SHR-4597 by dry powder inhalation

  • PlaceboDrug

    Placebo by dry powder inhalation

Study groups in NCT06385964
Study groupRoleWhat they receive
SHR-4597ExperimentalNot described
Receives: Drug: SHR-4597
SHR-4597 PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and severity of inhalant adverse events after 4 days of single inhalation of SHR4597 in healthy subjects

    Measured: 4 days for healthy subjects

  2. Incidence and severity of inhalant adverse events after 16 days of multiple inhalation of SHR4597 in asthmatic patients,

    Measured: 16 days for asthmatic patients.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2024
  2. Study start7 May 2024
  3. Primary completion19 Feb 2025
  4. Study completion19 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06385964
Sponsor's protocol ID
SHR-4597-101
Status last verified
Mar 2026
First submitted
23 Apr 2024
Last updated
6 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SHR-4597 in people with Healthy Subjects and Asthmatic Patients, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of inhalant adverse events after 4 days of single inhalation of SHR4597 in healthy subjects (time frame: 4 days for healthy subjects). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06385964.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.

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