A Phase I Study of SHR -2001 in Healthy Subjects

Inclusion criteria

• Obtain informed consent from participants before the start of any study related activities. Participants must have a full understanding of the purpose and significance of the trial, and be willing to comply with the trial protocol;
• Age 18 ~ 55 years old (including boundary value), male or female;
• Weight ≥ 45 kg, body mass index (BMI) ranging 19 ~ 28 kg/m2 (including boundary value);
• Participants who are overtly healthy as determined by medical history and physical examination.;
• Participants and their partners have no fertility plan and voluntarily use highly effective contraception. Female subjects must have a negative serum pregnancy test and be non-lactating.

Exclusion criteria

• Those who have serious systemic diseases within 3 months before screening or administration, and the investigator believes that there may be safety risks;
• Those who have serious infection, severe trauma or major surgery within 6 months before screening or administration; those who plan to undergo surgery during the trial;
• Inactivated vaccine received within 2 weeks prior to randomization or live attenuated vaccine within 3 months prior to randomization, or intended to be vaccinated during the study period;