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Comparing of the Pharmacokinetics, Immunogenicity and Safety of MV088 and Prolia® in Healthy Adults.

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ClinicalTrials.gov Identifier: NCT04673799
Recruitment Status : Not yet recruiting
First Posted : December 17, 2020
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
Kunming Pharmaceuticals, Inc.

Study Description
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Brief Summary:
A Randomized, Double-blind and Parallel Group Study to Compare the Pharmacokinetics, Immunogenicity and Safety of MV088 and Prolia® in Healthy Adults.

Condition or disease Intervention/treatment Phase
Healthy Drug: MV088 injection Drug: Prolia® injection Phase 1

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 Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Denosumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: MV088
MV088 injection (60mg) by subcutaneous injection once on the first day
 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
 Drug: Prolia® injection
Prolia® injection (60mg) by subcutaneous injection once on the first day


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Safety evaluation of MV088/Prolia [ Time Frame: 126 days ]
    To characterize the Safety evaluation of MV088/Prolia after the first day administer

  8. Immunogenicity evaluation of MV088/Prolia [ Time Frame: 126 days ]
    To characterize the Immunogenicity evaluation of MV088/Prolia after the first day administer


Eligibility Criteria
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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
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Duo Gao 008613032237118 duo.gao@kpc.com.cn

Sponsors and Collaborators
Kunming Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Xin Li, ph.D The Third Hospital of Changsha
Principal Investigator: Jianchang He, ph.D Yunnan Provincial Hospital of Traditional Chinese Medicine
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Denosumab
Bone Density Conservation Agents
Physiological Effects of Drugs