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

• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04798326
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Actual Duration (Months): 8.1
• Patients Per Site Per Month: 14.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bone Tumor	Drug: MW032; Drug: Xgeva®	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jun 25, 2019
• Actual Primary Completion Date: Jan 10, 2020
• Actual Study Completion Date: Feb 26, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Area under the plasma concentration-time curve (AUC0-t ) [Day0-Day161]

2. Maximum serum concentration (Cmax) [Day0-Day161]

Secondary Outcome Measures

1. Adverse events(AE) [Day0-Day161]

   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.

2. serum CTX1 [Day0-Day161]

   CTX1 is a serum type I collagen C-terminal peptide to detect the bone metastasis events.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PKUCare Luzhong Hospital	Zibo	Shandong	China	255400

Sponsors and Collaborators

• Mabwell (Shanghai) Bioscience Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mabwell (Shanghai) Bioscience Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04798326
• Other Study ID Numbers: MW032-2019-CP101
• First Posted: Mar 15, 2021
• Last Update Posted: Mar 15, 2021
• Last Verified: Mar 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mabwell (Shanghai) Bioscience Co., Ltd.: Denosumab; Biosimilar
• Additional relevant MeSH terms: Bone Neoplasms

Study Results

No Results Posted as of Mar 15, 2021