A Trial of SHR-1905 in Healthy Subjects and Subjects With Mild Asthma (NCT04905602) | Clinical Trial Compass
CompletedPhase 1
A Trial of SHR-1905 in Healthy Subjects and Subjects With Mild Asthma
China86 participantsStarted 2021-06-15
Plain-language summary
This study is a phase 1 single dose escalation study of SHR-1905 in healthy subjects and subjects with mild asthma. The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of SHR-1905 in healthy subjects and subjects with mild asthma.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. Ability to understand the trial procedures and possible adverse events, volunteers to participate in the trial, and provides written informed consent, be able to comply with all the requirements and able to complete the study.
✓. Male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form.
✓. Total body weight ≥ 45 kg, body mass index (BMI) between 18 and 28 kg/m2 at screening.
✓. For healthy subjects, no clinically significant abnormalities in medical history, general physical examination, vital signs, laboratory tests (hematology, urinalysis, blood chemistry, coagulation function and thyroid function) and ECG at the investigator's discretion during screening and baseline.
Exclusion criteria
✕. Known medical history of severe disease in cardiovascular, liver, kidney, digestive tract, mental, nerve, hematology, metabolic disorders, etc.
✕. Severe injuries or major surgeries within 6 months before screening or plan to do surgeries during the trial.
✕. Positive hepatitis B virus (HBsAg), hepatitis C virus (HCV-Ab), human immunodeficiency virus (HIV-Ab) at screening.
✕. Hyper/Hypotension which define as Systolic blood pressure (SBP) \>140mmHg or \<90mmHg, or Diastolic blood pressure (DBP)\>90mmHg or \<40mmHg at screening and at check in.
✕. Clinically significant abnormalities in 12-Lead ECG (e.g., For male QTcF \> 450msec, for female QTcF \> 470msec) at screening and at check in
What they're measuring
1
Adverse events
Timeframe: Start of Treatment to end of study (approximately 16 weeks)