Status:
COMPLETED
The PK/PD Study of A Single Subcutaneous Injection of SHR-1222 in Healthy Subjects
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Osteoporosis
Eligibility:
All Genders
45-59 years
Phase:
PHASE1
Brief 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 ...
Detailed Description
50 adult healthy subjects with 5 dose groups will be enrolled in the study, including six subjects in the lowest dose group, four of whom received the SHR-1209 and two of whom received the placebo. Th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 6 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03870100
Start Date
April 15 2019
End Date
January 6 2020
Last Update
June 16 2020
Active Locations (1)
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1
2nd Xiangya Hospital of Central South University
Changsha, China