AzTrials
AzTrials

Healthy DonorsPhase 1NCT06905847

Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Primary Efficacy of HSK39004 Suspension for Inhalation

A Phase 1 study testing HSK39004 in healthy, HSK39004 and HSK39004 in COPD in people with Healthy Donors, run by Haisco Pharmaceutical Group 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
Search all trials

Trial summary

To evaluate the safety, tolerability and pharmacokinetic characteristics of HSK39004 suspension for inhalation in single/multiple administration(s) in healthy subjects; to evaluate the safety,tolerability and efficacy of HSK39004 suspension for inhalation in multiple administrations in patients with Chronic… Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Donors
What is being tested?
HSK39004 in healthy, HSK39004 and HSK39004 in COPD
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
63 participants
Where
1 siteChina
Study dates
2 Sep 2024to 20 Mar 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 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • For healthy volenteers:
  • Voluntarily sign the informed consent form, understand the trialprocedures, and be willing to comply with all trial procedures andrestrictions;
  • 18 years to 45 years (inclusive), male and female;
  • Male subjects weight ≥50 kg and female subjects weight ≥45 kg. Body mass index (BMI) : 18-26 kg/m2 (inclusive) ;
  • Ability to perform acceptable and reproducible spirometry;
  • Normal lung function during the screening period, no airway obstruction, FEV1 and forced vital capacity(FVC) are at least 80% of the predicted values;
Show all 14Show fewer
  • Subjects are willing to voluntarily use effectivecontraceptives from screening to at least 3 months after the last dose administration.
  • For COPD patients:
  • Voluntarily sign the informed consent form, understand the trialprocedures, and be willing to comply with all trial procedures andrestrictions;
  • Age ≥ 40 years , male and female;
  • According to the diagnostic criteria of 2024 Practical Edition of Guidelines , the patient was diagnosed with COPD; The patient has chronic respiratory symptoms such as shortness of breath, chronic cough or expectoration, and/or a history of exposure to risk factors, and the results of pulmonary function tests show that post-bronchodilator spirometry demonstrate FEV1/FVC ratio of ≤0.70 ;
  • At screening: post-bronchodilator spirometry demonstrate FEV1/FVC ratio of ≤0.70 and FEV1 must be ≥40 % to ≤80% of predicted normal and FEV1 increased by ≥100ml compared with pre-bronchiectasis;
  • No regular treatment of COPD was performed before joining the study. COPD agents (except SABA and/or SAMA) that are contraindicated in the protocol may be discontinued during the screening and treatment;
  • Subjects are willing to voluntarily use effectivecontraceptives from screening to at least 3 months after the last dose administration.

Who cannot join

  • For healthy volenteers:
  • Have a history of severe and uncontrolled diseases, such ascardiovascular, respiratory, liver, gastrointestinal, endocrine,hematologic, mental/nervous systems diseases within 3 months prior to screening;
  • Have a history of any malignant tumors;
  • Normal or abnormal vital signs, physical examination, laboratory examination, electrocardiogram, and imageological examination have no clinical significance (only for healthy subjects);
  • Previous or current gastrointestinal, liver, kidney, or other disease known to interfere with drug absorption, distribution, metabolism, or excretion;
  • Acute respiratory infections occurred within 6 weeks before screening and/or before randomization;
Show all 28Show fewer
  • Have a history of high consumption of grapefruit juice, methylxanthinerich food or beverage (such as coffee, tea, cola, chocolate, energydrinks) ,consumption of grapefruit juice, methylxanthine-rich food within 48 hours before the administration;
  • Smoking more than 5 cigarettes per day within 3 months prior toscreening or smoking during the study (only for healthy subjects);
  • Average alcohol intake is more than 14 unit per week (1unit=10g alcohol , 1 unit=285 mL 4.9% alcohol beer, or 30 mL 40% alcohol spirit, or 100mL 12% alcohol wine) within the 3 months prior to screening;
  • Have a history of drug abuse prior to screening, or positive urine drug screen at screening (If COPD patients were false positives due to other medications, they can be retested after the medication is washed);
  • Blood donation (or blood loss) ≥400 mL within 3 months prior to the screening;
  • Subjects who have a allergic to any component of HSK39004 or allergic history to opiates;
  • Intolerance to this product or the same target drug;
  • Subjects who use any live vaccine within 30 days prior to screening;
  • Have participated in any clinical investigator within 3 months prior to screening;
  • A pregnant/lactating woman, or has a positive pregnancy test at screening or during the trial;
  • Not suitable for this study as judged by the investigator.
  • For COPD patients, in addition to meeting the above exclusion criteria, they should also:
  • Present with any of the following diseases: Alpha-1 antitrypsin deficiency, asthma, active pulmonary tuberculosis, lung cancer, pulmonary edema, cystic fibrosis, bronchiolitis obliterans, sarcoidosis (sarcoidosis), bronchiectasis, unstable sleep apnea, Or clinically significant pulmonary fibrosis, pulmonary hypertension, or interstitial lung disease determined by the study physician to be a safety risk to the patient and/or to affect the analysis of the study results;
  • Previous or current history of serious cardiovascular disease;
  • Have type 1 diabetes or poorly controlled type 2 diabetes (fasting blood glucose ≥10 mmol/L at screening);
  • During the screening period, the investigators determined that the patient's laboratory tests had clinically significant abnormalities that could pose a safety risk to the patient;
  • Patients who were hospitalized for COPD or infectious pneumonia within 8 weeks prior to screening and/or had acute exacerbations of COPD or infectious pneumonia between the screening period and prior to randomization, indicating the presence of an active infection;
  • Patients with acute exacerbations of moderate to severe COPD ≥2 times/year within 1 year before screening;
  • Acute exacerbations of COPD requiring treatment with oral or parenteral corticosteroids occurred within 8 weeks prior to screening;
  • Had lung volume reduction surgery within 1 year prior to lung resection or screening;
  • Patients who use oxygen therapy for long-trem and more than 12 hours per day;
  • Not suitable for this study as judged by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610044

Other trials in China

About this study

Official title: Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamics Characteristics of HSK39004 Suspension for Inhalation.

To evaluate the safety, tolerability and pharmacokinetic characteristics of HSK39004 suspension for inhalation in single/multiple administration(s) in healthy subjects; to evaluate the safety,tolerability and efficacy of HSK39004 suspension for inhalation in multiple administrations in patients with Chronic Obstructive Pulmonary Disease（COPD）.

Conditions
Healthy Donors
Being tested
HSK39004 in healthy, HSK39004, HSK39004 in COPD

What participants receive

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

  • HSK39004 in healthyDrug

    1.5-12mg

  • HSK39004Drug

    Placebo

  • HSK39004 in COPDDrug

    1.5-6mg

Study groups in NCT06905847
Study groupRoleWhat they receive
HSK39004 in healthy volenteersExperimentalSingle or multiple inhaled HSK39004
Receives: Drug: HSK39004 in healthy
PlaceboPlacebo comparatorPlacebo
Receives: Drug: HSK39004
HSK39004 in COPD patientsExperimentalmultiple inhaled HSK39004
Receives: Drug: HSK39004 in COPD

What is being measured

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

  1. adverse events

    The Incidence of adverse events as assessed by CTCAE v5.0

    Measured: From the enrollment of the subjects to 72 hours after the last administration

Secondary outcomes (6)

  1. AUC

    area under the concentration-time curve

    Measured: from 0 to 72 hours after administration

  2. Cmax

    maximum plasma concentration

    Measured: from 0 to 72 hours after administration

  3. t1/2

    half-life

    Measured: from 0 to 72 hours after administration

  4. Vz/F

    apparent volume of distribution

    Measured: from 0 to 72 hours after administration

  5. CL/F

    apparent clearance

    Measured: from 0 to 72 hours after administration

  6. Forced Expiratory Volume in the first second (FEV1) for patients with COPD

    Mean Change From Baseline in Peak FEV1, Mean Change From Baseline FEV1 to Morning Trough FEV1

    Measured: From 0 before first administration to 24 hours after last administration

Timeline

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

  1. First posted2 Apr 2025
  2. Study start2 Sep 2024
  3. Primary completion13 Jan 2025
  4. Study completion20 Mar 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
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06905847
Sponsor's protocol ID
HSK39004-101
Status last verified
Dec 2024
First submitted
31 Dec 2024
Last updated
2 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HSK39004 in healthy, HSK39004 and HSK39004 in COPD in people with Healthy Donors, run by Haisco Pharmaceutical Group 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 14 inclusion and 28 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 2 Apr 2025. 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?

adverse events (time frame: From the enrollment of the subjects to 72 hours after the last administration). 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 NCT06905847.

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 2 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in