> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/comparing-of-the-pk-pd-safety-and-immunogenicity-of-hs-20090-5d08817a-66cf-4f73-b9e4-9ebc315edaa0 > Record changed: 2026-10-13 # Comparing of the PK, PD, Safety and Immunogenicity of HS-20090 and Xgeva® in Healthy Adults NCT05777109 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05777109) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05777109) Recruitment status Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05777109) Participants 180 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05777109) Lead sponsor Jiangsu Hansoh Pharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05777109) Start date 2023-04-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05777109) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05777109) ## Title and summary **Summary** A Dual-center , Randomized, double-blinded and Parallel-controlled Study to Assess the Pharmacokinetic, pharmacodynamics, Safety and Immunogenicity of HS-20090 Injection and Xgeva® in Healthy Adults Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05777109) **Short title** Comparing of the PK, PD, Safety and Immunogenicity of HS-20090 and Xgeva® in Healthy Adults Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05777109) **Official title** A Dual-center, Randomized, Double-blinded and Parallel-controlled Study to Assess the Pharmacokinetic, Pharmacodynamics, Safety and Immunogenicity of HS-20090 Injection and Xgeva® in Healthy Adults Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05777109) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05777109) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05777109) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05777109) **Recruitment status** Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05777109) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05777109) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05777109) ## Dates **Completion date** 2024-04-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05777109) **First posted** 2023-03-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05777109) **Registry last updated** 2023-08-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05777109) **Primary completion date** 2024-04-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05777109) **Start date** 2023-04-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05777109) ## Size and sites **Participants** 180 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05777109) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05777109) **Planned participants** 180 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05777109) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05777109) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05777109) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05777109) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05777109) **Lead sponsor** Jiangsu Hansoh Pharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05777109) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05777109) ## Identifiers **Registry ID** NCT05777109 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05777109) **ClinicalTrials.gov ID** NCT05777109 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05777109) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05777109) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05777109) ## Outcomes ### Primary outcomes 1. AUC0-∞ Timeframe: 155days The area under the curve from time 0 extrapolated to infinite time 2. Cmax Timeframe: 155days Maximum concentration ### Secondary outcomes 1. AUC0-t Timeframe: 155days Area under the plasma concentration-time curve 2. Tmax Timeframe: 155days Time to reach Cmax 3. t1/2z Timeframe: 155days Terminal half-life 4. Vz/F Timeframe: 155days Apparent volume of distribution 5. CLz/F Timeframe: 155days Apparent clearance 6. Serum type 1 C-telopeptide(CTX1) Timeframe: 155days explore the pharmacodynamic profile by detecting the serum concentration of CTX1 7. Imin Timeframe: 155days The minimum observed concentration 8. TEmax Timeframe: 155days Time to reach the maximum inhibition rate 9. Emax Timeframe: 155days Maximum observed inhibition rate 10. AUEC0-t Timeframe: 155days Area under the plasma effect-time curve from time zero to last time of quantifiable concentrationthe 11. Adverse events(AE) Timeframe: 155days 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. 12. Antidrug antibody(ADA): Timeframe: 155days percentage of subjects positive for antidrug antibody 13. Neutralizing antibody(Nab) Timeframe: 155days percentage of subjects positive for Nab Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05777109) ## Eligibility **Sex** Male **Age groups** Adults **Minimum age** 18 Years **Maximum age** 50 Years **Healthy volunteers** Yes ### 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 and ≤50 years old(including the boundary value); - Subjects weighing ≥ 55 kg and ≤ 75 kg (weight difference in a single center is controlled within 10 kg), with a BMI between 19.0 and 26.0 kg/m2 (BMI = weight (kg)/height2 (m2)) (including borderline values). - The subject agrees to use effective contraception for at least 6 months from the screening date until after study dosing, and has no plans to have children or donate sperm within 6 months; - Physical examination, vital signs, laboratory examination, chest X-ray, B-ultrasound and electrocardiogram are normal, or the above tests are abnormal without clinically significance and have no effect on the test as judged by the investigator; - ECG examination: corrected QT interval (QTcF) < 450 ms. ### Exclusion criteria - Occurred or suffering from osteomyelitis or ONJ (OsteoNecrosis of the Jaw) 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; - Subjects with any previous or current clinically serious diseases such as circulatory, endocrine, neurological, digestive, respiratory, genitourinary, hematological, immunological, psychiatric, and metabolic abnormalities or any other diseases that can interfere with the study results. - Positive screening for hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, Acquired Immune Deficiency Syndrome (AIDS) antibodies, and syphilis spirochete antibodies. - Abnormal blood calcium: current hypocalcemia or hypercalcemia. Serum calcium outside the normal laboratory range; (Subjects should not apply calcium supplements for at least 8 hours prior to drawing blood for serum calcium screening assays.) - previous use of RANKL inhibitors or osteoclastogenesis inhibitory factor. - The subject is participating in another clinical study, or the first dose was administered less than 3 months after the last dose of the previous clinical study (or 5 half-lives of the study drug, whichever is longer). - Average daily smoking ≥ 5 cigarettes in the 3 months prior to randomization. - Prior history of alcohol abuse (14 units of alcohol per week: 1 unit = 360 mL of beer or 45 mL of spirits at 40% alcohol or 150 mL of wine), substance abuse or drug use. - Positive substance abuse screening or/and alcohol breath test screening prior to study administration. - Subjects who have donated blood within 3 months prior to administration, or have lost more than 400 ml of blood, or are scheduled to donate blood within 6 months. - Subjects who have had a significant change in physical status within 6 months prior to administration, or who have been performing strenuous exercise. - Subjects who, in the opinion of the investigator, have any factors that make participation in this trial inadvisable. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05777109) ## Sites - Haikou People's HospitalHaikou, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05777109) ## Related records ### Drugs (1) - [Denosumab](https://trialight.com/data/asset/denosumab-9ee8731d-42aa-4d04-abbd-9dffa084523f.md) ### Lead sponsors (1) - [Jiangsu Hansoh Pharmaceutical Co., Ltd.](https://trialight.com/data/company/jiangsu-hansoh-pharmaceutical-co-ltd-dceaa442-eec5-4a9d-96e7-43beea770993.md) ### Targets (1) - [TNFSF11](https://trialight.com/data/target/tnfsf11-f943913e-58f0-5f3e-b943-025022f2eab3.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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