Comparing of the Pharmacokinetics, Immunogenicity and Safety of MV088 and Prolia® in Healthy Adults.
- Registration Number
- NCT04673799
- Lead Sponsor
- Kunming Pharmaceuticals, Inc.
- Brief Summary
A Randomized, Double-blind and Parallel Group Study to Compare the Pharmacokinetics, Immunogenicity and Safety of MV088 and Prolia® in Healthy Adults.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 144
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prolia® Prolia® injection Prolia® injection (60mg) by subcutaneous injection once on the first day MV088 MV088 injection MV088 injection (60mg) by subcutaneous injection once on the first day
- Primary Outcome Measures
Name Time Method Pharmacokinetics of MV088/Prolia in plasma: Cmax 126 days To characterize the pharmacokinetic parameters#Cmax of MV088/Prolia after the first day administer
Pharmacokinetics of MV088/Prolia in plasma: AUC0-∞ 126 days To characterize the pharmacokinetic parameters#AUC0-∞ of MV088/Prolia after the first day administer
- Secondary Outcome Measures
Name Time Method Pharmacokinetics of MV088/Prolia in plasma: Vz/F 126 days To characterize the pharmacokinetic parameters#Vz/F of MV088/Prolia after the first day administer
Pharmacokinetics of MV088/Prolia in plasma: Tmax 126 days To characterize the pharmacokinetic parameters#Tmax of MV088/Prolia after the first day administer
Pharmacokinetics of MV088/Prolia in plasma: AUC0-t 126 days To characterize the pharmacokinetic parameters#AUC0-t of MV088/Prolia after the first day administer
Pharmacokinetics of MV088/Prolia in plasma: t1/2 126 days To characterize the pharmacokinetic parameters#t1/2 of MV088/Prolia after the first day administer
Safety evaluation of MV088/Prolia 126 days To characterize the Safety evaluation of MV088/Prolia after the first day administer
Pharmacokinetics of MV088/Prolia in plasma: CLz/F 126 days To characterize the pharmacokinetic parameters#CLz/F of MV088/Prolia after the first day administer
Pharmacokinetics of MV088/Prolia in plasma: λz 126 days To characterize the pharmacokinetic parameters#λz of MV088/Prolia after the first day administer
Immunogenicity evaluation of MV088/Prolia 126 days To characterize the Immunogenicity evaluation of MV088/Prolia after the first day administer