Overview

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.