Chronic Obstructive Pulmonary DiseasePhase 1NCT07035652
The Phase Ib Clinical Trial of the XH-S004 Tablet in Patients With Chronic Obstructive Pulmonary Disease (COPD) to Evaluate Its Safety, Tolerability, Pharmacokinetic Characteristics and Pharmacodynamic Characteristics After Multiple Administrations
A Phase 1 study testing XH-S004 20 mg, 40 mg or 60 mg in people with Chronic Obstructive Pulmonary Disease, run by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. at 1 site in China.
Trial summary
The objectives of the proposed study are to investigate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and prliminary efficacy of XH-S004 in moderate to severe COPD patients with a stale standards of care (SOC). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- XH-S004 20 mg, 40 mg or 60 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2025to 13 Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign the informed consent form (ICF);
- Male or Female participants ages 40-80 (inclusive);
- BMI ≥ 18.5 kg/m2 and ≤ 26 kg/m2, with male weight ≥50 kg and female weight ≥45 kg (inclusive);
- Patients diagnosed with COPD according to 2024 GOLD consensus had a medical record or relevant documentation proving a history of COPD for ≥12 months at screening visit;
- Current or former smokers with a smoking history of ≥10 pack-years;
- Post-bronchodilator FEV1/ forced vital capacity [FVC] ratio <0.70 and post-bronchodilator FEV1 % predicted >30% and ≤70%.
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- Sputum volume≥10ml/day at screening visit;
- with a documented history: 1) Moderate-to-severe COPD patients with a stable SOC therapy prior to signing ICF, including LABA, LAMA, LABA/LAMA, LABA/LAMA/ICS (evaluated by investigator to confirm the treatment regimen complies with clinical practice); Continuous use with a stable dosage for ≥1 month prior to randomization; Medication compliance between 80% and 120% from signing ICF to randomization; 2) Acute exacerbation history of ≥2 moderate or ≥1 severe requiring hospitalization within 12 months prior to screening.
- Medical Research Council (MRC) Dyspnea Scale grade ≥2.
- COPD Assessment Test (CAT)≥10
Who cannot join
- Have a primary diagnosis of asthma as determined by the investigator;
- During screening period, WBC<the lower limit of normal range, or absolute neutrophil count<the lower limit of normal range;
- During screening period, blood eosinophils ≥300 cells/microliter;
- Pregnant and lactating females
Trial locations and contacts
1 site in 1 country.
China1 site
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100000
About this study
The objectives of the proposed study are to investigate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and prliminary efficacy of XH-S004 in moderate to severe COPD patients with a stale standards of care (SOC).
Read the detailed description
This study is a multicenter, double-blind, placebo-controlled, up-titration study conducted in china, aimed at evaluating the safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of XH-S004 administered once daily for 140 days in COPD patients.
This study plans to enroll 81 COPD patients. Patients who sign the informed consent form will be screened according to the enrollment criteria, and randomly divided into 2 groups in 2:1 ratio (XH-S004 group: 54 participants and placebo group: 27 participants). Participants in XH-S004 group will receive XH-S004 20 mg for 28 days in treatment period 1, then up-titrated to XH-S004 40 mg for 84 days in treatment period 2, finally continue with XH-S004 60 mg for 28 days in treamtment period 3. Participants in placebo group will receive matching placebo from day 1 to day 140 (140 days in total).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- XH-S004 20 mg, 40 mg or 60 mg, Placebo
- Keywords
- COPD, Active neutrophil elastase
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XH-S004 20 mg, 40 mg or 60 mgOther
Administered once per day for 140 days.
PlaceboOther
Administered once per day for 140 days.
| Study group | Role | What they receive |
|---|---|---|
| Arm1: Participant Group | Experimental | Up-titration design: prticipants received XH-S004 20 mg once daily (QD) from day 1 to day 28 in treatment period 1, XH-S004 40 mg once daily (QD) from day 29 to day 112 in treatment period 2, and XH-S004 60 mg once daily (QD) from day 113 to day 140 in treatment period 3.
Pharmaceutical form: Tablets Route of administration: Oral Receives: Other: XH-S004 20 mg, 40 mg or 60 mg |
| Participant Group | Placebo comparator | Participants received the matching placebo once daily (QD) from day 1 to day 140 in treatment period 1, treatment period 2 and treatment period 3.
Pharmaceutical form: Tablets Route of administration: Oral Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Experienced at Least One of Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs)
Measured: From randomisation to study completion, up to 168 days
Secondary outcomes (7)
Time to reach maximum plasma concentration (Tmax)
Measured: From randomisation to study completion, up to 168 days
Maximum measured concentration (Cmax) of XH-S004
Measured: From randomisation to study completion, up to 168 days
Maximum measured concentration of XH-S004 at steady state (Cmax,ss)
Measured: From randomisation to study completion, up to 168 days
Area Under the Plasma Concentration-time Curve (AUC) of XH-S004
Measured: From randomisation to study completion, up to 168 days
Change From Baseline in Blood Concentration of Active Neutrophil Elastase (NE)
Measured: From randomisation to study completion, up to 168 days
Change from baseline in pre-brondilator FEV1 after first drug administration.
FEV1 was used to assess lung function and is the maximum amount of air that can be forced out in one second after taking a deep breath.
Measured: At baseline, day 28, day 112 and day 140
Change from baseline in post-brondilator FEV1 after first drug administration
FEV1 was used to assess lung function and is the maximum amount of air that can be forced out in one second after taking a deep breath.
Measured: At baseline, day 28, day 112 and day 140
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start15 Jul 2025
- Primary completion13 Nov 2026 (estimated)
- Study completion13 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Parallel Assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07035652
- Sponsor's protocol ID
- XH-S004-102
- Status last verified
- Sep 2026
- First submitted
- 16 Jun 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Phase Ib Clinical Trial of the XH-S004 Tablet in Patients With Chronic Obstructive Pulmonary Disease (COPD) to Evaluate Its Safety, Tolerability, Pharmacokinetic Characteristics and Pharmacodynamic Characteristics After Multiple Administrations
- ClinicalTrials.gov ID
- NCT07035652
- Acronym / sponsor ID
- XH-S004-102
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Active neutrophil elastase
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 13 Nov 2026 (estimated)
- Study completion
- 13 Nov 2026 (estimated)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of the proposed study are to investigate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and prliminary efficacy of XH-S004 in moderate to severe COPD patients with a stale standards of care (SOC).
Detailed description
This study is a multicenter, double-blind, placebo-controlled, up-titration study conducted in china, aimed at evaluating the safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of XH-S004 administered once daily for 140 days in COPD patients.
This study plans to enroll 81 COPD patients. Patients who sign the informed consent form will be screened according to the enrollment criteria, and randomly divided into 2 groups in 2:1 ratio (XH-S004 group: 54 participants and placebo group: 27 participants). Participants in XH-S004 group will receive XH-S004 20 mg for 28 days in treatment period 1, then up-titrated to XH-S004 40 mg for 84 days in treatment period 2, finally continue with XH-S004 60 mg for 28 days in treamtment period 3. Participants in placebo group will receive matching placebo from day 1 to day 140 (140 days in total).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Arm1: Participant Group | Experimental | Other: XH-S004 20 mg, 40 mg or 60 mgUp-titration design: prticipants received XH-S004 20 mg once daily (QD) from day 1 to day 28 in treatment period 1, XH-S004 40 mg once daily (QD) from day 29 to day 112 in treatment period 2, and XH-S004 60 mg once daily (QD) from day 113 to day 140 in treatment period 3. Pharmaceutical form: Tablets Route of administration: Oral |
| Participant Group | Placebo comparator | Other: PlaceboParticipants received the matching placebo once daily (QD) from day 1 to day 140 in treatment period 1, treatment period 2 and treatment period 3. Pharmaceutical form: Tablets Route of administration: Oral |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Sign the informed consent form (ICF);
- Male or Female participants ages 40-80 (inclusive);
- BMI ≥ 18.5 kg/m2 and ≤ 26 kg/m2, with male weight ≥50 kg and female weight ≥45 kg (inclusive);
- Patients diagnosed with COPD according to 2024 GOLD consensus had a medical record or relevant documentation proving a history of COPD for ≥12 months at screening visit;
- Current or former smokers with a smoking history of ≥10 pack-years;
Key exclusion criteria (4 listed)
- Have a primary diagnosis of asthma as determined by the investigator;
- During screening period, WBC<the lower limit of normal range, or absolute neutrophil count<the lower limit of normal range;
- During screening period, blood eosinophils ≥300 cells/microliter;
- Pregnant and lactating females
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XH-S004 20 mg, 40 mg or 60 mgAdministered once per day for 140 days. | Other | Arm1: Participant Group |
| PlaceboAdministered once per day for 140 days. | Other | Participant Group |
Primary outcome
Percentage of Participants Who Experienced at Least One of Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time frame: From randomisation to study completion, up to 168 days
7 secondary outcomes
Time to reach maximum plasma concentration (Tmax)
Time frame: From randomisation to study completion, up to 168 days
Maximum measured concentration (Cmax) of XH-S004
Time frame: From randomisation to study completion, up to 168 days
Maximum measured concentration of XH-S004 at steady state (Cmax,ss)
Time frame: From randomisation to study completion, up to 168 days
Area Under the Plasma Concentration-time Curve (AUC) of XH-S004
Time frame: From randomisation to study completion, up to 168 days
Change From Baseline in Blood Concentration of Active Neutrophil Elastase (NE)
Time frame: From randomisation to study completion, up to 168 days
Change from baseline in pre-brondilator FEV1 after first drug administration.
Time frame: At baseline, day 28, day 112 and day 140
Change from baseline in post-brondilator FEV1 after first drug administration
Time frame: At baseline, day 28, day 112 and day 140
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing XH-S004 20 mg, 40 mg or 60 mg in people with Chronic Obstructive Pulmonary Disease, run by Shanghai Fosun Pharmaceutical Industrial Development 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 10 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 25 Sep 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?
This study is still under way. Results are not available in the source record yet.
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?
Percentage of Participants Who Experienced at Least One of Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs) (time frame: From randomisation to study completion, up to 168 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2026.