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

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

A randomized, double-blind and parallel group study to compare the pharmacokinetic, safety and pharmacodynamic of MW032 and Xgeva® in healthy adults.

Study Overview

• Status: Completed
• Conditions: Bone Tumor
• Intervention / Treatment: Drug: MW032; Drug: Xgeva®

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shandong
    • Zibo, Shandong, China, 255400
      • PKUCare Luzhong Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MW032; MW032 injection (120mg) by subcutaneous injection once on the first day of treatment.	Drug: MW032; Subjects would receive a single 120mg (1.7 mL) of MW032 through subcutaneous injection, on the first day of treatment.
Active Comparator: Xgeva®; Xgeva® injection (120mg) by subcutaneous injection once on the first day of treatment.	Drug: Xgeva®; Subjects would receive a single 120mg (1.7 mL) of Xgeva® through subcutaneous injection, on the first day of treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the plasma concentration-time curve (AUC0-t )	Day0-Day161
Maximum serum concentration (Cmax)	Day0-Day161

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day0-Day161
serum CTX1	CTX1 is a serum type I collagen C-terminal peptide to detect the bone metastasis events.	Day0-Day161

Collaborators and Investigators

• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2019
• Primary Completion (Actual): January 10, 2020
• Study Completion (Actual): February 26, 2020

Study Registration Dates

• First Submitted: March 12, 2021
• First Submitted That Met QC Criteria: March 12, 2021
• First Posted (Actual): March 15, 2021

Study Record Updates

• Last Update Posted (Actual): March 15, 2021
• Last Update Submitted That Met QC Criteria: March 12, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Biosimilar; Denosumab
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Musculoskeletal Diseases; Bone Diseases; Bone Neoplasms
• Other Study ID Numbers: MW032-2019-CP101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No