A Clinical Trial to Evaluate the Efficacy and Safety of HRS-9821 Inhalation Suspension in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

NCT07640451 | Not Yet Recruiting Phase 2

• 1 other identifier: HRS-9821-201
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The study is being conducted to evaluate the efficacy and safety of HRS-9821 for patients with COPD, and to explore the reasonable dosage of HRS-9821 for patients with COPD.

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• Changes in peak FEV1 (forced expiratory volume in one second) after 28 days of treatment.

  From baseline to 28 days after treatment.

Secondary Outcomes (6)

• Changes in FEV1 area under the curve versus time from 0 to 12 hours (AUC0-12h) and 0 to 4 hours (AUC0-4h) after 1, 14 and 28 days of treatment.

  During 28 days of treatment.

• Changes in peak FEV1 after 1 and 14 days of treatment.

  After 1 and 14 days of treatment.

• Changes in trough FEV1 after 1, 14 and 28 days of treatment.

  After 1, 14 and 28 days of treatment.

• Changes in FVC (forced vital capacity) during 28 days of treatment.

  During 28 days of treatment.

• Changes of in SGRQ (St. George's Respiratory Questionnaire), CAT (COPD Assessment Test), mMRC (modified Medical Research Council） score during 28 days of treatment.

  During 28 days of treatment.

Other Outcomes (9)

• Incidence and severity of adverse events (AEs) during the 7-week study period.

  During the 7-week study period.

• Plasma concentration of HRS-9821 after 1, 14 and 28 days of treatment.

  After 1, 14 and 28 days of treatment.

• Peak concentration after 1, 14 and 28 days of treatment.

  After 1, 14 and 28 days of treatment.

Study Arms (4)

HRS-9821 Group - Dose 1

EXPERIMENTAL

HRS-9821 Inhalation Suspension, Dose 1.

Drug: HRS-9821 Inhalation Suspension

HRS-9821 Group - Dose 2

EXPERIMENTAL

HRS-9821 Inhalation Suspension, Dose 2.

Drug: HRS-9821 Inhalation Suspension

HRS-9821 Placebo Group - Dose 1

PLACEBO COMPARATOR

HRS-9821 Placebo Inhalation Suspension, Dose 1.

Drug: HRS-9821 Placebo Inhalation Suspension

HRS-9821 Placebo Group - Dose 2

PLACEBO COMPARATOR

HRS-9821 Placebo Inhalation Suspension, Dose 2.

Drug: HRS-9821 Placebo Inhalation Suspension

Interventions

HRS-9821 Placebo Inhalation Suspension DRUG

HRS-9821 Placebo Inhalation Suspension.

HRS-9821 Placebo Group - Dose 1; HRS-9821 Placebo Group - Dose 2

HRS-9821 Inhalation Suspension DRUG

HRS-9821 Inhalation Suspension.

HRS-9821 Group - Dose 1; HRS-9821 Group - Dose 2

Eligibility Criteria

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

You may qualify if:

• Age ≥ 40 years old and \< 80 years old, male or female.
• Meet the weight standard.
• Smoking history ≥ 10 pack-years.
• COPD has been diagnosed ≥ 1 year.
• weeks before screening, the background treatment for COPD was stable.
• FEV1/FVC \< 0.7, 30% ≤ FEV1 ≤ 80%.
• mMRC score ≥ 2.
• The inspection and medication can be completed as required.
• Non-pregnant and breastfeeding state.
• Able and willing to provide a written informed consent.

You may not qualify if:

• History of life-threatening COPD.
• Other pulmonary diseases that may affect the efficacy evaluation of this study.
• Concurrent diseases other than COPD that may affect lung function.
• History of asthma.
• Pulmonary heart disease requiring clinical intervention, or moderate to severe pulmonary hypertension.
• Malignant tumors within 5 years.
• Uncontrolled severe cardiovascular and cerebrovascular diseases within 1 year.
• Unstable diseases.
• Acute exacerbation of COPD within 12 weeks, hospitalization for COPD or pneumonia within 6 months.
• Infection in the lungs or other parts occurs within 16 weeks and requires treatment.
• Immunosuppression.
• Uncontrolled hypertension.
• Lung resection, surgical lung volume reduction or endoscopic treatment for COPD.
• Undergone major surgery or planned surgery within 14 months.
• Abnormal chest images have clinical significance.

Sponsors & Collaborators

• Guangdong Hengrui Pharmaceutical Co., Ltd: lead

Study Sites (1)

Shanghai Tongji Hospital

Shanghai, Shanghai Municipality, 200065, 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

Si Chen, M.M

CONTACT

+86-0518-82342973; si.chen.sc96@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: HRS-9821 inhalation suspension compared with placebo.

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 10, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 10, 2026

Record last verified: 2026-06

Locations

CN (1)