A Trial of HRS-9813 in Healthy Subjects
The study is being conducted to evaluate the safety and pharmacokinetics of HRS-9813 after multiple oral administration in healthy subjects.
| Condition(s) | Idiopathic Pulmonary Fibrosis/Progressive Pulmonary Fibrosis |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | The study is being conducted to evaluate the safety and pharmacokinetics of HRS-9813 after multiple oral administration in healthy subjects. |
| Who can participate | Inclusion Criteria: 1. Voluntarily sign the informed consent form before the start of activities related to this trial, and be able to fully understand the procedures, methods, contents and possible adverse reactions of this trial, and be willing to strictly abide by the clinical trial protocol to complete this trial. 2. Aged 18-45 years (inclusive), healthy male or female; 3. Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 19-26 kg/m2 (inclusive), body mass index (BMI) = weight (kg)/(height/100)2 (m2); 4. Physical examination, vital signs, 12-lead electrocardiogram, chest anteroposterior and lateral radiographs, abdominal ultrasound and laboratory tests during the screening and baseline periods were normal, or slightly abnormal but clinically insignificant as determ |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Guangdong Hengrui Pharmaceutical Co., Ltd |
| Locations | Shanghai, Shanghai Municipality, China |
| Start date | 2025-02-17 |
| NCT ID | NCT06821464 |
| Official listing | https://clinicaltrials.gov/study/NCT06821464 |