- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04673799
Comparing of the Pharmacokinetics, Immunogenicity and Safety of MV088 and Prolia® in Healthy Adults.
December 13, 2020 updated by: Kunming Pharmaceuticals, Inc.
A Randomized, Double-blind and Parallel Group Study to Compare the Pharmacokinetics, Immunogenicity and Safety of MV088 and Prolia® in Healthy Adults.
A Randomized, Double-blind and Parallel Group Study to Compare the Pharmacokinetics, Immunogenicity and Safety of MV088 and Prolia® in Healthy Adults.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
144
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Duo Gao
- Phone Number: 008613032237118
- Email: duo.gao@kpc.com.cn
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: MV088
MV088 injection (60mg) by subcutaneous injection once on the first day
|
MV088 injection (60mg) by subcutaneous injection once on the first day
|
ACTIVE_COMPARATOR: Prolia®
Prolia® injection (60mg) by subcutaneous injection once on the first day
|
Prolia® injection (60mg) by subcutaneous injection once on the first day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics of MV088/Prolia in plasma: Cmax
Time Frame: 126 days
|
To characterize the pharmacokinetic parameters#Cmax of MV088/Prolia after the first day administer
|
126 days
|
Pharmacokinetics of MV088/Prolia in plasma: AUC0-∞
Time Frame: 126 days
|
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
Time Frame: 126 days
|
To characterize the pharmacokinetic parameters#AUC0-t of MV088/Prolia after the first day administer
|
126 days
|
Pharmacokinetics of MV088/Prolia in plasma: Tmax
Time Frame: 126 days
|
To characterize the pharmacokinetic parameters#Tmax of MV088/Prolia after the first day administer
|
126 days
|
Pharmacokinetics of MV088/Prolia in plasma: t1/2
Time Frame: 126 days
|
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
Time Frame: 126 days
|
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
Time Frame: 126 days
|
To characterize the pharmacokinetic parameters#Vz/F of MV088/Prolia after the first day administer
|
126 days
|
Pharmacokinetics of MV088/Prolia in plasma: λz
Time Frame: 126 days
|
To characterize the pharmacokinetic parameters#λz of MV088/Prolia after the first day administer
|
126 days
|
Safety evaluation of MV088/Prolia
Time Frame: 126 days
|
To characterize the Safety evaluation of MV088/Prolia after the first day administer
|
126 days
|
Immunogenicity evaluation of MV088/Prolia
Time Frame: 126 days
|
To characterize the Immunogenicity evaluation of MV088/Prolia after the first day administer
|
126 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Xin Li, ph.D, The Third Hospital of Changsha
- Principal Investigator: Jianchang He, ph.D, Yunnan Provincial Hospital of Traditional Chinese Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
February 22, 2021
Primary Completion (ANTICIPATED)
October 18, 2021
Study Completion (ANTICIPATED)
October 18, 2021
Study Registration Dates
First Submitted
December 13, 2020
First Submitted That Met QC Criteria
December 13, 2020
First Posted (ACTUAL)
December 17, 2020
Study Record Updates
Last Update Posted (ACTUAL)
December 17, 2020
Last Update Submitted That Met QC Criteria
December 13, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KYJT-MV088-I01
- CTR20202419 (OTHER: National Medical Products Administration)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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