Safety, Tolerability, and Pharmacokinetics of Single Doses of HC022 in Healthy Subjects.

Korábbi kezelés

• Have participated in other clinical trials within 3 months, or within the 5 half lives of the investigational drug prior to screening, whichever is longer;
• Serious infection, serious injuries, or major surgical procedures within 6 months prior to Screening；

Más betegség

• History of or positive test results at screening for the following: for human immunodeficiency virus (HIV), hepatitis C virus antibody (HCV Ab), hepatitis B virus (defined as positive for HBsAg or HBcAb or HBeAg)；
• History of or current diagnosis of active tuberculosis (TB), or untreated latent TB infection (LTBI) at screening；
• History of severe herpes infection or zoster viral infection；
• History of alcohol or substance abuse, a positive urine drug or alcohol test at Day -1；
• History of severe allergic or anaphylactic reactions or history of allergic reactions likely to be exacerbated by any component of the study drug；
• Any disease or conditons that are not suitable for participation in this study as determined by the Investigator；

• Ability to understand the purpose and risks of the study and provide signed and dated informed consent and comply with study requirements;
• Aged 18 to 55 years old, inclusive, male or female;
• 3.A body weigh ≥ 50 kg for male , and a body weigh ≥ 45 kg for female, and must have a body mass index between 19 and 28 kilogram per square meter (kg/m2)；
• Be in good health as based on medical history, physical examination, vital signs, laboratory tests, chest radiographs, abdominal ultrasound and 12-lead ECG；
• All women of childbearing potential and all men must practice highly effective contraception during the study and for 6 months (for female) or 3 months (for male) after their dose of study treatment；