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

Osteoporosis, Postmenopausal Clinical Trial

— MW031  

Official title:

A Single Center, Randomized, Double-blind , Single-dose, and Parallel Group Study to Compare the Pharmacokinetic, Safety and Pharmacodynamic of MW031 and Prolia® in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04798313
• Other study ID #: MW031-2020-CP101
• Status: Completed
• Phase: Phase 1
• Start date: June 2, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2021
• Source: Mabwell (Shanghai) Bioscience Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 31, 2020
• Est. primary completion date: December 7, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal

Intervention

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

Locations

Country	Name	City	State
China	PKUCare Luzhong Hospital	Zibo	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Mabwell (Shanghai) Bioscience Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration-time curve (AUC0-t )		Day0-Day140
Primary	Maximum serum concentration (Cmax)		Day0-Day140
Secondary	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-Day140
Secondary	serum CTX1	CTX1 is a serum type I collagen C-terminal peptide to detect the bone metastasis events.	Day0-Day140