Clinical trial NCT04798326: Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of MW032 and Xgeva® in Healthy Adults
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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bone Tumor
Keywords: Denosumab
Biosimilar
Lead sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-03-15
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Area under the plasma concentration-time curve (AUC0-t )
timeFrame: Day0-Day161
measure: Maximum serum concentration (Cmax)
timeFrame: Day0-Day161
Secondary outcomes:
measure: Adverse events(AE)
timeFrame: Day0-Day161
measure: serum CTX1
timeFrame: Day0-Day161
Other outcomes:
Locations:
city: Zibo
country: China
facility: PKUCare Luzhong Hospital
state: Shandong
Study officials:
References: