Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of MW031 and Prolia® in Healthy Adults
- Registration Number
- NCT04798313
- Lead Sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 120
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prolia® Prolia® Prolia® injection (60mg) by subcutaneous injection once on the first day of treatment. MW031 MW031 MW031 injection (60mg) by subcutaneous injection once on the first day of treatment.
- Primary Outcome Measures
Name Time Method Area under the plasma concentration-time curve (AUC0-t ) Day0-Day140 Maximum serum concentration (Cmax) Day0-Day140
- Secondary Outcome Measures
Name Time Method serum CTX1 Day0-Day140 CTX1 is a serum type I collagen C-terminal peptide to detect the bone metastasis events.
Adverse events(AE) Day0-Day140 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.
Trial Locations
- Locations (1)
PKUCare Luzhong Hospital
🇨🇳Zibo, Shandong, China