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

Use the Protocol Title. The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study Following A Single Subcutaneous Injection of SHR-1222 in Healthy Subjects

NCT03870100•Jiangsu HengRui Medicine Co., Ltd.

View on ClinicalTrials.gov

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.

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. The other three groups have 11 subjects in each group, 9 administered SHR-1222 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.

Eligibility

Age

45 - 59 years

Sex

ALL

Healthy Volunteers

Yes

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;
+8 more criteria

Locations (1)

2nd Xiangya Hospital of Central South University

Changsha, China

Key Dates

Start Date

April 15, 2019

Primary Completion Date

October 14, 2019

Completion Date

January 6, 2020

Last Updated

June 16, 2020

Enrollment

ACTUAL participants

Conditions

Osteoporosis

Interventions

SHR-1222

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 16, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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

Inclusion Criteria

Exclusion Criteria

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