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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 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-02-27

No results posted yet for this study

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

Interventions

DRUG

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

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

DRUG

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

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

DRUG

Moxifloxacin Hydrochloride Tablets

Moxifloxacin Hydrochloride Tablets

Sponsors & Collaborators

  • Guangdong Hengrui Pharmaceutical Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-11
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07116915 on ClinicalTrials.gov