Healthy
Conditions
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.
Interventions
DRUGMV088 injection
MV088 injection (60mg) by subcutaneous injection once on the first day
DRUGProlia® injection
Prolia® injection (60mg) by subcutaneous injection once on the first day
Sponsors
Kunming Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
randomized、double-blind、parallel-group、single-dosed、positive control
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Aged ≥18 years or ≤65 years, male(including the boundary value). 2. 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). 3. 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. 4. 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
1. Have participated in any drug or medical device trials or are participating in other clinical trials within 3 months prior to first administration. 2. Occurred or suffering from osteomyelitis or ONJ (mandibular necrosis) previously. 3. 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. 4. Occurred or suffering hypocalcemia. 5. Have taken any medicine (including Chinese herbal medicine) within 14 days before the first administration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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: 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: AUC0-t | 126 days | To characterize the pharmacokinetic parameters#AUC0-t 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 |
| Immunogenicity evaluation of MV088/Prolia | 126 days | To characterize the Immunogenicity evaluation 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 |
| Pharmacokinetics of MV088/Prolia in plasma: Tmax | 126 days | To characterize the pharmacokinetic parameters#Tmax of MV088/Prolia after the first day administer |
Contacts
Primary ContactDuo Gao
Outcome results
None listed