A Study on the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of SHR-7012 in Healthy Adults
The age of signing the informed consent form was between 18 and 55 years old (inclusive), both male and female.
Body weight ≥50 kg for men and ≥45 kg for women during the screening period, body mass index (BMI = weight (kg)/ height 2(m2)) between 19.0 and 26.0 kg/m2 (including boundary value)
Female participants of childbearing potential and male participants whose partners were fertile women had no plans to give birth, sperm or egg donation within 6 months after signing the informed consent, and voluntarily took highly effective contraceptive methods. Female participants of childbearing potential had to have a serum pregnancy test with a negative result during the screening and baseline periods
Female participants: not pregnant or lactatin
Patients with previous or current clinical acute or chronic diseases of the circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, or metabolic disorders, who were judged by the investigator to be unsuitable for enrollment
Patients had a history of severe herpesvirus infection, a history of malignancy, or current active infection
Patients with chronic or recurrent infection requiring treatment within 12 months before screening
A screening test for tuberculosis infection (interferon-γ release assay, IGRA) was positive