Study of Bioavailability, Pharmacodynamics and Safety of SHR-1209 Administered by Single Subcutaneous Injection at Different Sites in Healthy Volunteers

This is an interventional basic science trial for Hypercholesterolemia and Hyperlipidemia Read More

Inclusion Criteria:

1. Understanding the research procedures and methods, being able to complete the research in accordance with the procedure requirements, and sign the informed consent;
2. The age on the date of signing the informed consent must be ≥18 years old and ≤55 years old;
3. Body mass index (BMI) at screening period must be ≥18.5 kg/m2 and <30.0 kg/m2, weight of male must≥ 50.0 kg and <90.0 kg, and female≥ 45.0 kg and <90.0 kg;
4. The subjects and their female partners are willing to have no reproductive plan from 2 weeks before screening to 6 months after the administration of the study drug, and voluntarily take effective contraceptive measures and do not plan to donate sperm or ovum.

Exclusion Criteria:

1. History of the following diseases or treatments:

   Diseases that affect drug absorption, distribution, metabolism, and excretion determined by the investigator; Serious infection within 3 months before screening; History of drug allergy or atopic allergic disease (asthma, urticaria).

2. Any one of the following tests at Screening period or Baseline period:

   Human immunodeficiency virus antibody (HIV-Ab), syphilis serological examination, hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab) positive; Positive blood pregnancy test.

3. General situation:

   Have a history of drug use or drug abuse; Women who are pregnant or breastfeeding.

4. Subjects who are considered by the investigator to have any other factors which are not suitable for participating in this study.