Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of MW031 and Prolia® in Healthy Adults

NCT ID: NCT04798313

Last Updated: 2021-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-02
• Study Completion Date: 2020-12-31

Brief Summary

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

The secondary objective are to assess the Clinical safety and immunogenicity similarity of single and subcutaneous injections of MW031 and Prolia® in healthy volunteers.

At the same time, preliminary evaluate the pharmacodynamic similarity between MW031 and Prolia®.

Subjects would receive a single 60mg（1mL）of MW031 or Prolia® through subcutaneous injection.

Conditions

Osteoporosis, Postmenopausal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

MW031

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

Group Type: EXPERIMENTAL

MW031

Intervention Type: DRUG

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

Prolia®

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

Group Type: ACTIVE_COMPARATOR

Prolia®

Intervention Type: DRUG

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

Interventions

MW031

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

Intervention Type: DRUG

Prolia®

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Mabwell (Shanghai) Bioscience Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

PKUCare Luzhong Hospital

Zibo, Shandong, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 36892190 (View on PubMed)

Other Identifiers

MW031-2020-CP101

Identifier Type: -

Identifier Source: org_study_id