Clinical trial · Interventional
Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of MW032 and Xgeva® in Healthy Adults
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
NCT04798326CI-TRIAL-00050643MW032completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A randomized, double-blind and parallel group study to compare the pharmacokinetic, safety and pharmacodynamic of MW032 and Xgeva® in healthy adults.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Tumor | Bone Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MW032 | Drug | — | UNRESOLVED |
| Xgeva® | Drug | Denosumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MW032
- description
- MW032 injection (120mg) by subcutaneous injection once on the first day of treatment.
- interventionNames
- Drug: MW032
- type
- ACTIVE_COMPARATOR
- label
- Xgeva®
- description
- Xgeva® injection (120mg) by subcutaneous injection once on the first day of treatment.
- interventionNames
- Drug: Xgeva®
Primary outcomes (2)
- measure
- Area under the plasma concentration-time curve (AUC0-t )
- timeFrame
- Day0-Day161
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.