Comparing of the Pharmacokinetics, Immunogenicity and Safety of MV088 and Prolia® in Healthy Adults.
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ClinicalTrials.gov Identifier: NCT04673799 |
Recruitment Status : Unknown
Verified December 2020 by Kunming Pharmaceuticals, Inc..
Recruitment status was: Not yet recruiting
First Posted : December 17, 2020
Last Update Posted : December 17, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: MV088 injection Drug: Prolia® injection | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 144 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | randomized、double-blind、parallel-group、single-dosed、positive control |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-blind and Parallel Group Study to Compare the Pharmacokinetics, Immunogenicity and Safety of MV088 and Prolia® in Healthy Adults. |
Estimated Study Start Date : | February 22, 2021 |
Estimated Primary Completion Date : | October 18, 2021 |
Estimated Study Completion Date : | October 18, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: MV088
MV088 injection (60mg) by subcutaneous injection once on the first day
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Drug: MV088 injection
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
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Drug: Prolia® injection
Prolia® injection (60mg) by subcutaneous injection once on the first day |
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Safety evaluation of MV088/Prolia [ Time Frame: 126 days ]To characterize the Safety evaluation of MV088/Prolia after the first day administer
- Immunogenicity evaluation of MV088/Prolia [ Time Frame: 126 days ]To characterize the Immunogenicity evaluation of MV088/Prolia after the first day administer

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04673799
Contact: Duo Gao | 008613032237118 | duo.gao@kpc.com.cn |
Principal Investigator: | Xin Li, ph.D | The Third Hospital of Changsha | |
Principal Investigator: | Jianchang He, ph.D | Yunnan Provincial Hospital of Traditional Chinese Medicine |
Responsible Party: | Kunming Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT04673799 |
Other Study ID Numbers: |
KYJT-MV088-I01 CTR20202419 ( Other Identifier: National Medical Products Administration ) |
First Posted: | December 17, 2020 Key Record Dates |
Last Update Posted: | December 17, 2020 |
Last Verified: | December 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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