Status:
UNKNOWN
Comparing of the Pharmacokinetics, Immunogenicity and Safety of MV088 and Prolia® in Healthy Adults.
Lead Sponsor:
Kunming Pharmaceuticals, Inc.
Conditions:
Healthy
Eligibility:
MALE
18-65 years
Phase:
PHASE1
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 he...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 18 2021
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT04673799
Start Date
February 22 2021
End Date
October 18 2021
Last Update
December 17 2020
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