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

NCT07035652 | Not Yet Recruiting Phase 1

• 1 other identifier: XH-S004-102
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD; Active neutrophil elastase

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Experienced at Least One of Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs)

  From randomisation to study completion, up to 168 days

Secondary Outcomes (7)

• Time to reach maximum plasma concentration (Tmax)

  From randomisation to study completion, up to 168 days

• Maximum measured concentration (Cmax) of XH-S004

  From randomisation to study completion, up to 168 days

• Maximum measured concentration of XH-S004 at steady state (Cmax,ss)

  From randomisation to study completion, up to 168 days

• Area Under the Plasma Concentration-time Curve (AUC) of XH-S004

  From randomisation to study completion, up to 168 days

• Change From Baseline in Blood Concentration of Active Neutrophil Elastase (NE)

  From randomisation to study completion, up to 168 days

Study Arms (2)

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

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

Other: Placebo

Interventions

XH-S004 20 mg, 40 mg or 60 mg OTHER

Administered once per day for 140 days.

Arm1: Participant Group

Placebo OTHER

Administered once per day for 140 days.

Participant Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• S-INFINITY Pharmaceuticals Co., Ltd: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Bin Cao

CONTACT

+86 13911318339; caobin_ben@163.com

Yeming Wang

CONTACT

+86 18810663558; wwyymm_love@163.c0m

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: June 25, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): November 13, 2026
• Study Completion (Estimated): November 13, 2026
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)