A Randomized, Double-blind and Parallel Group Study to Compare the Pharmacokinetics, Immunogenicity and Safety of MV088 and Prolia® in Healthy Adults.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
144
MV088 injection (60mg) by subcutaneous injection once on the first day
Prolia® injection (60mg) by subcutaneous injection once on the first day
Pharmacokinetics of MV088/Prolia in plasma: Cmax
To characterize the pharmacokinetic parameters#Cmax of MV088/Prolia after the first day administer
Time frame: 126 days
Pharmacokinetics of MV088/Prolia in plasma: AUC0-∞
To characterize the pharmacokinetic parameters#AUC0-∞ of MV088/Prolia after the first day administer
Time frame: 126 days
Pharmacokinetics of MV088/Prolia in plasma: AUC0-t
To characterize the pharmacokinetic parameters#AUC0-t of MV088/Prolia after the first day administer
Time frame: 126 days
Pharmacokinetics of MV088/Prolia in plasma: Tmax
To characterize the pharmacokinetic parameters#Tmax of MV088/Prolia after the first day administer
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 126 days
Pharmacokinetics of MV088/Prolia in plasma: λz
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To characterize the pharmacokinetic parameters#λz of MV088/Prolia after the first day administer
Time frame: 126 days
Safety evaluation of MV088/Prolia
To characterize the Safety evaluation of MV088/Prolia after the first day administer
Time frame: 126 days
Immunogenicity evaluation of MV088/Prolia
To characterize the Immunogenicity evaluation of MV088/Prolia after the first day administer
Time frame: 126 days