Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of MW031 and Prolia® 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, safety and pharmacodynamic of MW031 and Prolia® 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 and subcutaneous injections of MW031 and Prolia® in healthy volunteers. The secondary objective are to assess the Clinical safety and immunogenicity similarity of single and subcutaneous injections of MW031 and Prolia® in healthy volunteers. At the same time, preliminary evaluate the pharmacodynamic similarity between MW031 and Prolia®. Subjects would receive a single 60mg（1mL）of MW031 or Prolia® through subcutaneous injection.

Official Title
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A Single Center, Randomized, Double-blind , Single-dose, and Parallel Group Study to Compare the Pharmacokinetic, Safety and Pharmacodynamic of MW031 and Prolia® in Healthy Adults

Conditions
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Osteoporosis, Postmenopausal

Intervention / Treatment
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* Drug: MW031
* Drug: Prolia®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18-65 years old (including 18 and 65 years old), healthy male subjects. Body mass index (BMI) within the range 19-28kg/m2. History, physical examination, laboratory tests and test related items of inspection were normal or mildly abnormal clinically insignificant. Volunteered to participate in this clinical trial, capable of giving written informed consentan. The subject (including the subject's partner) takes effective contraceptive measures. Exclusion Criteria: Nervous/mental, respiratory system, cardiovascular system, digestive system, blood and lymphatic system, endocrine system, skeletal and muscular system diseases, liver and kidney dysfunction, or any other diseases and physiological conditions that may affect the results of the study. Occurred or suffering from osteomyelitis or ONJ (mandibular necrosis) previously. Clinical laboratory abnormalities of clinical significance, or other clinical findings suggest clinically significant following diseases (including, but not limited to the gastrointestinal tract, kidney, liver, nerve, blood, endocrine, cancer, lung, immune, mental or cardiovascular disease). Subject has viral hepatitis (including hepatitis B and hepatitis C), AIDS antibodies, and Treponema pallidum antibodies. Those who have used the following drugs within 1 month or 5 half-lives (whichever is longer) before participating in this study, including but not limited to: estrogen-containing contraceptives, bisphosphonates, fluoride, hormone replacement Treatment (ie tibolone, estrogen, estrogen-like compounds, such as raloxifene), calcitonin, strontium, parathyroid hormone or its derivatives, vitamin D supplements (>1000 IU/day), corticosteroids (inhaled or topical corticosteroids can be used 2 weeks before enrollment), anabolic hormone drugs, calcitriol, diuretics.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MW031<br>MW031 injection (60mg) by subcutaneous injection once on the first day of treatment. | Drug: MW031<br>* Subjects would receive a single 60mg (1 mL) of MW031 through subcutaneous injection, on the first day of treatment.<br>|
| Active Comparator: Prolia®<br>Prolia® injection (60mg) by subcutaneous injection once on the first day of treatment. | Drug: Prolia®<br>* Subjects would receive a single 60mg (1 mL) of Prolia® through subcutaneous injection, on the first day of treatment.<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 ) |  | Day0-Day140 | 
| Maximum serum concentration (Cmax) |  | Day0-Day140 | 

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. | Day0-Day140 | 
| serum CTX1 | CTX1 is a serum type I collagen C-terminal peptide to detect the bone metastasis events. | Day0-Day140 |