The PK/PD Study of A Single Subcutaneous Injection of SHR-1222 in Healthy Subjects

• Status: Completed
• Trial end date: 2020-01-06
• Target enrollment: 0
• Participant gender: All

Summary

This is a Single Center, Randomized, Double-Blind, Dose Escalation, Placebo Parallel Controlled PhaseⅠClinical study to Evaluate the Safety, Tolerability and Pharmacokinetics, Pharmacodynamics with A Single Subcutaneous Injection of SHR-1222 in Healthy Subjects.

The primary objective of this study is to investigate the safety and tolerability of a range of subcutaneous SHR-1222 in healthy subjects. Secondary objectives are to determine the pharmacokinetics (PK) and pharmacodynamics(PD) profile of SHR-1222 in healthy subjects including assessment of immunogenicity.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Criteria

Inclusion Criteria:

• Signed informed consent;

• Male or postmenopausal female;

• Age ≥45 and ≤59 years old;

• The body mass index (BMI) ≥18.5kg/m2 and ≤28 kg/m2;

• T value of areal bone mineral density on any lumbar spine (L1-L4) or collum femoris>-2.5 and <-1;

• The comprehensive physical examination is eligible or slightly abnormal but the researchers determine no clinical implication;

• No smoking, alcohol or drugs abuse.

Exclusion Criteria:

• Any disease affecting bone metabolism;

• Past medical history of cerebral infarction or cerebral arterial thrombosis;

• Past medical history of myocardial infarction;

• Administration of the following drugs within 6m: Hormone replacement therapy, Calcitonin Parathyroid hormone (or any derivative), Supplemental Vitamin D>1,000 IU/day, Glucocorticosteroids (inhaled or topical corticosteroids administered more than 2 weeks before the enrollment date are allowed), Anabolic steroids, Calcitriol and available analogues, thiazide diuretics;

• Administration of the following drugs within 12m: Bisphosphonates, Fluoride for osteoporosis;

• A bone fracture within the previous 6 months;

• A lumbar spine L1-L4 or femoral neck T-score ≤-2.5;

• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or gamma pancreatic acyl transferase (GGT) or total bilirubin, more than 1.5 x ULN during screening;

• 3 months prior to screening involved in any drug clinical subjects;

• Subjects determined by the researchers have any food, dietary supplement or drugs that affect SHR-1222 absorption, distribution, metabolism and excretion in 4 weeks prior to screening or within 5 half-lives;

• Serious infection, trauma or major surgery in 4 weeks prior to screening;

• A surgery plan during the study;

• Blood donation and transfusion in 3 months prior to screening;

• Unstable thyroid dysfunction in 6 months prior to screening;

• Human immunodeficiency virus antibody (HIV-ab), syphilis serological examination, hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCV-ab) were positive;

• Intolerant to venous blood collection;

• 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

• Subjects with any other situation should not be involved, which determined by the researchers.