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Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of MW032 and Xgeva® in Healthy Adults (MW032)

Primary Purpose

Bone Tumor

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
MW032
Xgeva®
Sponsored by
Mabwell (Shanghai) Bioscience Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Tumor focused on measuring Denosumab, Biosimilar

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • PKUCare Luzhong Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MW032

Xgeva®

Arm Description

MW032 injection (120mg) by subcutaneous injection once on the first day of treatment.

Xgeva® injection (120mg) by subcutaneous injection once on the first day of treatment.

Outcomes

Primary Outcome Measures

Area under the plasma concentration-time curve (AUC0-t )
Maximum serum concentration (Cmax)

Secondary Outcome Measures

Adverse events(AE)
The adverse medical events that occur after the clinical trial subjects receive the test drug do not necessarily have a causal relationship with the treatment.
serum CTX1
CTX1 is a serum type I collagen C-terminal peptide to detect the bone metastasis events.

Full Information

First Posted
March 12, 2021
Last Updated
March 12, 2021
Sponsor
Mabwell (Shanghai) Bioscience Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04798326
Brief Title
Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of MW032 and Xgeva® in Healthy Adults
Acronym
MW032
Official Title
A Single Center, Randomized, Double-blind , Single-dose, and Parallel Group Study to Compare the Pharmacokinetic, Safety and Pharmacodynamic of MW032 and Xgeva® in Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 25, 2019 (Actual)
Primary Completion Date
January 10, 2020 (Actual)
Study Completion Date
February 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mabwell (Shanghai) Bioscience Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A randomized, double-blind and parallel group study to compare the pharmacokinetic, safety and pharmacodynamic of MW032 and Xgeva® in healthy adults.
Detailed Description
This is a phase I, single center, randomized, double-blind and parallel group clinical trial. The primary objective is to assess the pharmacokinetic similarity of single and subcutaneous injections of MW032 and Xgeva® in healthy volunteers. The secondary objective are to assess the Clinical safety and immunogenicity similarity of single and subcutaneous injections of MW032 and Xgeva® in healthy volunteers. At the same time, preliminary evaluate the pharmacodynamic similarity between MW032 and Xgeva®. Subjects would receive a single 120mg（1.7mL）of MW032 or Xgeva® through subcutaneous injection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Tumor
Keywords
Denosumab, Biosimilar

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MW032
Arm Type
Experimental
Arm Description
MW032 injection (120mg) by subcutaneous injection once on the first day of treatment.
Arm Title
Xgeva®
Arm Type
Active Comparator
Arm Description
Xgeva® injection (120mg) by subcutaneous injection once on the first day of treatment.
Intervention Type
Drug
Intervention Name(s)
MW032
Intervention Description
Subjects would receive a single 120mg (1.7 mL) of MW032 through subcutaneous injection, on the first day of treatment.
Intervention Type
Drug
Intervention Name(s)
Xgeva®
Intervention Description
Subjects would receive a single 120mg (1.7 mL) of Xgeva® through subcutaneous injection, on the first day of treatment.
Primary Outcome Measure Information:
Title
Area under the plasma concentration-time curve (AUC0-t )
Time Frame
Day0-Day161
Title
Maximum serum concentration (Cmax)
Time Frame
Day0-Day161
Secondary Outcome Measure Information:
Title
Adverse events(AE)
Description
The adverse medical events that occur after the clinical trial subjects receive the test drug do not necessarily have a causal relationship with the treatment.
Time Frame
Day0-Day161
Title
serum CTX1
Description
CTX1 is a serum type I collagen C-terminal peptide to detect the bone metastasis events.
Time Frame
Day0-Day161

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
PKUCare Luzhong Hospital
City
Zibo
State/Province
Shandong
ZIP/Postal Code
255400
Country
China

12. IPD Sharing Statement

Learn more about this trial

Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of MW032 and Xgeva® in Healthy Adults

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