A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics for a Single Dose of HRS-9821 Powder for Inhalation and Inhalation Suspension Administered in Healthy Subjects and Multiple Doses in Patients With COPD.

NCT07116915 | Recruiting Phase 1

• 1 other identifier: HRS-9821-I-102
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to evaluate the safety and tolerability of HRS-9821 Powder for Inhalation and inhalation suspension administered in a single dose in healthy individuals and multiple doses in patients with COPD

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the rate of adverse events

  The screening period lasted until 40 days after administration

Secondary Outcomes (5)

• Plasma drug concentration after administration

  The screening period lasted until 40 days after administration

• Changes in heart rate from baseline after a single dose of HRS-9821 aerosol inhalation in healthy subjects。

  The screening period lasted until 29 days after administration

• Changes in QT interval from baseline after a single dose of HRS-9821 aerosol inhalation in healthy subjects.

  The screening period lasted until 29 days after administration

• Lung epithelial lining fluid (ELF) drug concentrations based on alveolar lavage (BAL) measurements in healthy subjects after a single dose of HRS-9821 aerosol inhalation

  The screening period lasted until 29 days after administration

• Theoretical intracellular drug concentrations based on alveolar lavage fluid (BALF) cells measured by alveolar lavage (BAL) after a single dose of HRS-9821 aerosol inhalation in healthy subjects.

  The screening period lasted until 29 days after administration

Study Arms (3)

HRS-9821 Powder for Inhalation or HRS-9821 inhalation suspension

EXPERIMENTAL

Participants inhaled HRS-9821 powder either as a single dose or for 12 days.

Drug: HRS-9821 Powder for Inhalation/HRS-9821 inhalation suspension

HRS-9821 Powder for Inhalation placebo or or HRS-9821 inhalation suspension placebo

PLACEBO COMPARATOR

Participants received a single dose or 12 consecutive days of inhaled powdered placebo with HRS-9821.

Drug: HRS-9821 Powder for Inhalation placebo/HRS-9821 inhalation suspension placebo

Moxifloxacin

ACTIVE COMPARATOR

Moxifloxacin is oral

Drug: Moxifloxacin Hydrochloride Tablets

Interventions

HRS-9821 Powder for Inhalation/HRS-9821 inhalation suspension DRUG

HRS-9821 Powder for Inhalation. HRS-9821 inhalation suspension

HRS-9821 Powder for Inhalation or HRS-9821 inhalation suspension

HRS-9821 Powder for Inhalation placebo/HRS-9821 inhalation suspension placebo DRUG

HRS-9821 Powder for Inhalation placebo. HRS-9821 inhalation suspension placebo

HRS-9821 Powder for Inhalation placebo or or HRS-9821 inhalation suspension placebo

Moxifloxacin Hydrochloride Tablets DRUG

Moxifloxacin Hydrochloride Tablets

Moxifloxacin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent was obtained to participate in the trial
• Body weight ≥45 kg, BMI 18-33 kg/m2 (both ends included)
• The 12-lead ECG was normal or abnormal but clinically insignificant until randomization
• Contraception was strict from the time informed consent was signed until 1 month (for subjects receiving HRS-9821/ placebo) or 3 months (for male subjects receiving moxifloxacin) after the last dose
• All study regulations and procedures were followed and inhalation devices used in the study were used correctly during the study
• Vital signs were normal at screening
• Pulmonary function was normal during screening
• No smoking or smoking cessation ≥12 months before screening, and previous smoking history \<5 pack-years；
• Male or female, aged 40-75 years;
• Patients diagnosed with COPD;
• A post-bronchodilator FEV1 /FVC \< 0.7,40% ≤FEV1 \< 80% of the predicted value,;
• Smoking history of≥ 10 pack-years;
• Normal chest X-ray examination results at screening;
• Supporting discontinuation of COPD-related medications before randomization；

You may not qualify if:

• Mean QTcF ≥ 450 ms at screening；
• Persons who had donated blood or had massive blood loss (\> 400 ml) within 4 weeks before screening or who were interested in donating blood during the study
• Receipt of the investigational drug or device within 4 weeks before randomization or less than 5 times the half-life of the drug, whichever was greater;
• Patients who had difficulty in blood collection or could not tolerate venipuncture in the past, such as dizzy with needles or blood
• History of malignancy in any organ system
• Known allergies to salbutamol, study medication, or any excipients in the formulation
• Known previous infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); Or positive HIV (according to a trial-site SOP), treponema pallidum antibody, HBV surface antigen, or HCV antibody before randomization
• History of alcohol abuse
• History of drug abuse and drug dependence in the past 5 years；
• Positive for alcohol or substance abuse test before randomization
• During the study, surgery or treatment that might interfere with the conduct of the study was planned；
• Unable or unwilling to fully adhere to the study protocol
• Mentally or legally incapacitated
• There were any other reasons for the subject not to participate in the study in the opinion of the investigator;
• Use of a strong/moderate potency drug that inhibits or induces the hepatic drug-metabolizing enzyme CYP3A4 14 days before the first dose;

Sponsors & Collaborators

• Guangdong Hengrui Pharmaceutical Co., Ltd: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610044, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Huanhuan Huang

CONTACT

+0518-81220121; huanhuan.huang.hh30@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: August 12, 2025
• Study Start: August 11, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2025-07

Locations

CN (1)