NCT04673799

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
144

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Feb 2021

Typical duration for phase_1 healthy

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

February 22, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2021

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

8 months

First QC Date

December 13, 2020

Last Update Submit

December 13, 2020

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetics of MV088/Prolia in plasma: Cmax

    To characterize the pharmacokinetic parameters#Cmax of MV088/Prolia after the first day administer

    126 days

  • Pharmacokinetics of MV088/Prolia in plasma: AUC0-∞

    To characterize the pharmacokinetic parameters#AUC0-∞ of MV088/Prolia after the first day administer

    126 days

Secondary Outcomes (8)

  • Pharmacokinetics of MV088/Prolia in plasma: AUC0-t

    126 days

  • Pharmacokinetics of MV088/Prolia in plasma: Tmax

    126 days

  • Pharmacokinetics of MV088/Prolia in plasma: t1/2

    126 days

  • Pharmacokinetics of MV088/Prolia in plasma: CLz/F

    126 days

  • Pharmacokinetics of MV088/Prolia in plasma: Vz/F

    126 days

  • +3 more secondary outcomes

Study Arms (2)

MV088

EXPERIMENTAL

MV088 injection (60mg) by subcutaneous injection once on the first day

Drug: MV088 injection

Prolia®

ACTIVE COMPARATOR

Prolia® injection (60mg) by subcutaneous injection once on the first day

Drug: Prolia® injection

Interventions

MV088 injectionDRUG

MV088 injection (60mg) by subcutaneous injection once on the first day

MV088
Prolia® injectionDRUG

Prolia® injection (60mg) by subcutaneous injection once on the first day

Prolia®

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Denosumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Xin Li, ph.D

    The Third Hospital of Changsha

    PRINCIPAL INVESTIGATOR

  • Jianchang He, ph.D

    Yunnan Provincial Hospital of Traditional Chinese Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Duo Gao

CONTACT

008613032237118duo.gao@kpc.com.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized、double-blind、parallel-group、single-dosed、positive control
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2020

First Posted

December 17, 2020

Study Start

February 22, 2021

Primary Completion

October 18, 2021

Study Completion

October 18, 2021

Last Updated

December 17, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share