Comparing of the Pharmacokinetics, Immunogenicity and Safety of MV088 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 Pharmacokinetics, Immunogenicity and Safety of MV088 and Prolia® in Healthy Adults.

Detailed Description
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This is a phase I, double center, randomized, double-blind, single dose and parallel group clinical trial . The primary objective is to assess the pharmacokinetic similarity of MV088 and Prolia® in healthy volunteers. The secondary objectives is to assess the similarity of clinical safety and immunogenicity of MV088 and Prolia® in healthy volunteers.

Official Title
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A Randomized, Double-blind and Parallel Group Study to Compare the Pharmacokinetics, Immunogenicity and Safety of MV088 and Prolia® in Healthy Adults.

Conditions
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Healthy

Intervention / Treatment
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* Drug: MV088 injection
* Drug: Prolia® injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged ≥18 years or ≤65 years, male(including the boundary value). The body weight is within the range of 50 70kg (including the boundary value) and the body mass index（BMI） is within the range of 19.0 26.0kg/m2 (including the boundary value). 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. The volunteers are able to communicate well with the researchers, understand and comply with the requirements of the study, and are expected to participate in all follow-up visits (no long-term plans to leave the study site). Exclusion Criteria: Have participated in any drug or medical device trials or are participating in other clinical trials within 3 months prior to first administration. 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. Occurred or suffering hypocalcemia. Have taken any medicine (including Chinese herbal medicine) within 14 days before the first administration.

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
Interventional Model Description: randomized、double-blind、parallel-group、single-dosed、positive control
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MV088<br>MV088 injection (60mg) by subcutaneous injection once on the first day | Drug: MV088 injection<br>* MV088 injection (60mg) by subcutaneous injection once on the first day<br>|
| Active Comparator: Prolia®<br>Prolia® injection (60mg) by subcutaneous injection once on the first day | Drug: Prolia® injection<br>* Prolia® injection (60mg) by subcutaneous injection once on the first day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of MV088/Prolia in plasma: Cmax | To characterize the pharmacokinetic parameters#Cmax of MV088/Prolia after the first day administer | 126 days | 
| Pharmacokinetics of MV088/Prolia in plasma: AUC0-∞ | To characterize the pharmacokinetic parameters#AUC0-∞ of MV088/Prolia after the first day administer | 126 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of MV088/Prolia in plasma: AUC0-t | To characterize the pharmacokinetic parameters#AUC0-t of MV088/Prolia after the first day administer | 126 days | 
| Pharmacokinetics of MV088/Prolia in plasma: Tmax | To characterize the pharmacokinetic parameters#Tmax of MV088/Prolia after the first day administer | 126 days | 
| Pharmacokinetics of MV088/Prolia in plasma: t1/2 | To characterize the pharmacokinetic parameters#t1/2 of MV088/Prolia after the first day administer | 126 days | 
| Pharmacokinetics of MV088/Prolia in plasma: CLz/F | To characterize the pharmacokinetic parameters#CLz/F of MV088/Prolia after the first day administer | 126 days | 
| Pharmacokinetics of MV088/Prolia in plasma: Vz/F | To characterize the pharmacokinetic parameters#Vz/F of MV088/Prolia after the first day administer | 126 days | 
| Pharmacokinetics of MV088/Prolia in plasma: λz | To characterize the pharmacokinetic parameters#λz of MV088/Prolia after the first day administer | 126 days | 
| Safety evaluation of MV088/Prolia | To characterize the Safety evaluation of MV088/Prolia after the first day administer | 126 days | 
| Immunogenicity evaluation of MV088/Prolia | To characterize the Immunogenicity evaluation of MV088/Prolia after the first day administer | 126 days |