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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.

ConditionCOPD
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGuangdong Hengrui Pharmaceutical Co., Ltd

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Drug

    HRS-9821 Powder for Inhalation. 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

  • Moxifloxacin Hydrochloride Tablets

    Drug

    Moxifloxacin Hydrochloride Tablets

Treatment groups

160 Participants
are divided into 3 treatment groups
Group A: HRS-9821 Powder for Inhalation or HRS-9821 inhalation suspensionExperimental treatment 1 intervention
Group B: HRS-9821 Powder for Inhalation placebo or or HRS-9821 inhalation suspension placeboPlacebo comparator 1 intervention
Group C: MoxifloxacinActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in the rate of adverse events

Time frame
The screening period lasted until 40 days after administration

Secondary outcomes

1

Plasma drug concentration after administration

Time frame
The screening period lasted until 40 days after administration
2

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

Time frame
The screening period lasted until 29 days after administration
3

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

Time frame
The screening period lasted until 29 days after administration
4

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

Time frame
The screening period lasted until 29 days after administration

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangdong Hengrui Pharmaceutical Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
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