Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of HS-20090 and Xgeva® in Healthy Adults

Study Overview
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Brief Summary
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A randomized, double-blind and parallel group study to compare the pharmacokinetic, pharmacodynamic, safety and immunogenicity of HS-20090 120mg（1.7ml）and Xgeva® in healthy adults.

Detailed Description
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This is a phase I, single center, randomized, double-blind and parallel group clinical trial . The primary objective is to assess the pharmacokinetic similarity of single subcutaneously injection of HS-20090 or Xgeva® in healthy volunteers. The secondary objectives are to assess the Clinical safety and immunogenicity similarity of single subcutaneously injection of HS-20090 or Xgeva® in healthy volunteers. Meanwhile，observing the pharmacodynamic similarity of HS-20090 to Xgeva® preliminarily.

Official Title
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A Randomized, Double-blinded and Parallel Study to Assess the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of HS-20090 and Xgeva® in Healthy Adults

Conditions
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Bone Metastasis From Solid Tumors

Intervention / Treatment
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* Drug: HS-20090
* Drug: Xgeva®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sign the informed consent form and fully understand the test content, process and possible adverse reactions, and be able to complete the study according to the test plan requirements; Healthy males, Aged ≥18 years or ≤50 years old(including the boundary value); Agree to take effective contraceptive measures throughout the study period until at least 6 months after the last drug is administered; Clinical laboratory examination, chest X-ray, abdominal B-ultrasound, electrocardiogram, physical examination, vital signs and various examinations are normal or abnormal without clinical significance. Exclusion Criteria: Occurred or suffering from osteomyelitis or ONJ (mandibular necrosis) previously; The dental or jaw disease that is active, requiring oral surgery; or planned for invasive dental surgery during the study; or dental or oral surgery wounds have not healed; Serum calcium levels are outside the normal range of the laboratory. Subject has positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result viral hepatitis (including hepatitis B and hepatitis C), or positive HIV antibodies, or positive test for syphilis. The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 3 months or 5 half-lives (whichever is longer). Prior use of medications within 6 months before and during the study. This includes medications such as, but not limited to: Bisphosphonates Fluoride Calcitonin Strontium Parathyroid hormone or derivatives Supplemental vitamin D (>1000 IU/day) Glucocorticosteroids (topical corticosteroids administered more than 2 weeks prior to enrolment are allowed) Anabolic steroids Calcitriol Diuretics

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HS-20090<br>Subcutaneously injection of HS-20090 (120mg/1.7mL) once on the first day | Drug: HS-20090<br>* A human IgG2 monoclonal antibody with affinity and specificity for human RANKL<br>|
| Active Comparator: Xgeva®<br>Subcutaneously injection of Xgeva® (120mg/1.7mL) once on the first day | Drug: Xgeva®<br>* A human IgG2 monoclonal antibody with affinity and specificity for human RANKL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration-time curve (AUC0-t ) |  | 155days | 
| Cmax | maximum concentration | 155days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events(AE) | The adverse medical events that occur after the clinical trial subjects receive the test drug do not necessarily have a causal relationship with the treatment. | 155days | 
| Serum type 1 C-telopeptide(CTX1) | explore the pharmacodynamic profile by detecting the serum concentration of CTX1 | 155days |