Clinical trial · Interventional
Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of HS-20090 and Xgeva® in Healthy Adults
A Randomized, Double-blinded and Parallel Study to Assess the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of HS-20090 and Xgeva® in Healthy Adults
NCT04494373CI-TRIAL-00046416unknownPhase 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, pharmacodynamic, safety and immunogenicity of HS-20090 120mg(1.7ml)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 Metastasis From Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HS-20090 | Drug | — | UNRESOLVED |
| Xgeva® | Drug | Denosumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HS-20090
- description
- Subcutaneously injection of HS-20090 (120mg/1.7mL) once on the first day
- interventionNames
- Drug: HS-20090
- type
- ACTIVE_COMPARATOR
- label
- Xgeva®
- description
- Subcutaneously injection of Xgeva® (120mg/1.7mL) once on the first day
- interventionNames
- Drug: Xgeva®
Primary outcomes (2)
- measure
- Area under the plasma concentration-time curve (AUC0-t )
- timeFrame
- 155days
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Sign the informed consent form and fully understand the test content, process and possible adverse reactions, and be able to complete the study according to the test plan requirements; * Healthy males, Aged ≥18 years or ≤50 years old(including the boundary value); * Agree to take effective contraceptive measures throughout the study period until at least 6 months after the last drug is administered; * Clinical laboratory examination, chest X-ray, abdominal B-ultrasound, electrocardiogram, physical examination, vital signs and various examinations are normal or abnormal without clinical significance. Exclusion Criteria: * Occurred or suffering from osteomyelitis or ONJ (mandibular necrosis) previously; The dental or jaw disease that is active, requiring oral surgery; or planned for invasive dental surgery during the study; or dental or oral surgery wounds have not healed; * Serum calcium levels are outside the normal range of the laboratory. * Subject has positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result viral hepatitis (including hepatitis B and hepatitis C), or positive HIV antibodies, or positive test for syphilis. * The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 3 months or 5 half-lives (whichever is longer). * Prior use of medications within 6 months before and during the study. This includes medications such as, but not limited to: Bisphosphonates Fluoride Calcitonin Strontium Parathyroid hormone or derivatives Supplemental vitamin D (\>1000 IU/day) Glucocorticosteroids (topical corticosteroids administered more than 2 weeks prior to enrolment are allowed) Anabolic steroids Calcitriol Diuretics
References
Publications (1)
- DERIVEDLin Y, Yang H, Yang X, Guo C, Yang S, Yang G, Wu Q, Pan C, Sun C, Li C, He L, Huang J, Pei Q. Biosimilarity of HS-20090 to Denosumab in healthy Chinese subjects: a randomized, double-blinded, pharmacokinetics/pharmacodynamics study. Expert Opin Investig Drugs. 2022 Oct;31(10):1125-1132. doi: 10.1080/13543784.2022.2123737. Epub 2022 Sep 16. PMID 36112084