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

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

Treatments tested in this trial

  • HRS-9821 Powder for Inhalation/HRS-9821 inhalation suspension
  • HRS-9821 Powder for Inhalation placebo/HRS-9821 inhalation suspension placebo
  • Moxifloxacin Hydrochloride Tablets

Treatment groups

160 Participants
are divided into 3 treatment groups