NCT04798313

Brief Summary

A randomized, double-blind and parallel group study to compare the pharmacokinetic, safety and pharmacodynamic of MW031 and Prolia® in healthy adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2020

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 2, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2020

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 15, 2021

Completed
Last Updated

March 15, 2021

Status Verified

March 1, 2021

Enrollment Period

6 months

First QC Date

March 12, 2021

Last Update Submit

March 12, 2021

Conditions

Osteoporosis, Postmenopausal

Outcome Measures

Primary Outcomes (2)

  • Area under the plasma concentration-time curve (AUC0-t )

    Day0-Day140

  • Maximum serum concentration (Cmax)

    Day0-Day140

Secondary Outcomes (2)

  • Adverse events(AE)

    Day0-Day140

  • serum CTX1

    Day0-Day140

Study Arms (2)

MW031

EXPERIMENTAL

MW031 injection (60mg) by subcutaneous injection once on the first day of treatment.

Drug: MW031

Prolia®

ACTIVE COMPARATOR

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

Drug: Prolia®

Interventions

MW031DRUG

Subjects would receive a single 60mg (1 mL) of MW031 through subcutaneous injection, on the first day of treatment.

MW031
Prolia®DRUG

Subjects would receive a single 60mg (1 mL) of Prolia® through subcutaneous injection, on the first day of treatment.

Prolia®

Eligibility Criteria

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

You may qualify if:

  • Age: 18-65 years old (including 18 and 65 years old), healthy male subjects.
  • Body mass index (BMI) within the range 19-28kg/m2.
  • History, physical examination, laboratory tests and test related items of inspection were normal or mildly abnormal clinically insignificant.
  • Volunteered to participate in this clinical trial, capable of giving written informed consentan.
  • The subject (including the subject's partner) takes effective contraceptive measures.

You may not qualify if:

  • Nervous/mental, respiratory system, cardiovascular system, digestive system, blood and lymphatic system, endocrine system, skeletal and muscular system diseases, liver and kidney dysfunction, or any other diseases and physiological conditions that may affect the results of the study.
  • Occurred or suffering from osteomyelitis or ONJ (mandibular necrosis) previously.
  • Clinical laboratory abnormalities of clinical significance, or other clinical findings suggest clinically significant following diseases (including, but not limited to the gastrointestinal tract, kidney, liver, nerve, blood, endocrine, cancer, lung, immune, mental or cardiovascular disease).
  • Subject has viral hepatitis (including hepatitis B and hepatitis C), AIDS antibodies, and Treponema pallidum antibodies.
  • Those who have used the following drugs within 1 month or 5 half-lives (whichever is longer) before participating in this study, including but not limited to: estrogen-containing contraceptives, bisphosphonates, fluoride, hormone replacement Treatment (ie tibolone, estrogen, estrogen-like compounds, such as raloxifene), calcitonin, strontium, parathyroid hormone or its derivatives, vitamin D supplements (\>1000 IU/day), corticosteroids (inhaled or topical corticosteroids can be used 2 weeks before enrollment), anabolic hormone drugs, calcitriol, diuretics.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PKUCare Luzhong Hospital

Zibo, Shandong, 255400, China

Location

Related Publications (1)

  • Guo Y, Guo T, Di Y, Xu W, Hu Z, Xiao Y, Yu H, Hou J. Pharmacokinetics, pharmacodynamics, safety and immunogenicity of recombinant, fully human anti-RANKL monoclonal antibody (MW031) versus denosumab in Chinese healthy subjects: a single-center, randomized, double-blind, single-dose, parallel-controlled trial. Expert Opin Biol Ther. 2023 Jul-Dec;23(8):705-715. doi: 10.1080/14712598.2023.2178298. Epub 2023 Mar 9.

    PMID: 36892190DERIVED

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Denosumab

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2021

First Posted

March 15, 2021

Study Start

June 2, 2020

Primary Completion

December 7, 2020

Study Completion

December 31, 2020

Last Updated

March 15, 2021

Record last verified: 2021-03

Locations

CN(1)