The PK/PD Study of A Single Subcutaneous Injection of SHR-1209 in Healthy Subjects

Launched by JIANGSU HENGRUI MEDICINE CO., LTD. · Aug 14, 2018

Keywords

ClinConnect Summary

32 adult healthy subjects with 4 dose groups will be enrolled in the study, including two subjects in the lowest dose group, all of whom received the SHR-1209 without placebo control. The other three groups have 10 subjects in each group, 8 administered SHR-1209 and 2 administered placebo. The primary endpoint is the Safety and Tolerability : adverse events, vital signs, physical examination, laboratory examination, 12 lead electrocardiogram, injection site reactions, etc.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 and ≤45 years old;
• • 2. The body mass index (BMI) should be 19 or greater and \< 28kg/m2, the male weigh ≥50.0kg and \<90.0kg, and the female weigh ≥45.0kg and \<90.0kg;
• • 3. Serum LDL-C concentration≥2.0mmol/L and \< 4.1mmol/L;
• • 4. Fasting triglycerides \< 2.3 mmol/L;
• • 5. The comprehensive physical examination is eligible or slightly abnormal but the researchers determine no clinical implication.
• • 6. Signed informed consent.
• Exclusion Criteria:
• • 1. Subjects determined by the researchers have diseases that affect drug absorption, distribution, metabolism and excretion or low compliance;
• • 2. A clinical history of drug allergy or a history of atopic allergic diseases (asthma, urticaria, eczema dermatitis) or a known allergy to experimental or similar experimental drugs;
• • 3. Serum creatinine exceeded the upper limit of normal value (ULN) during screening;
• • 4. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or gamma pancreatic acyl transferase (GGT), more than 2 x ULN, or total bilirubin more than 1.5 x ULN during screening;
• • 5. Human immunodeficiency virus antibody (HIV-ab), syphilis serological examination, hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCV-ab) were positive;
• • 6. Subjects with previous malignant tumor diseases;
• • 7. 3 months prior to screening involved in any drug or medical device clinical subjects, or within 5 half-life of drugs (test drug half-life more than 3 months) before screening. etc