> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-comparing-the-pharmacokinetic-similarity-of-mb09-and-24ea61a5-9188-47c7-97e2-c8785c96d0d6 > Record changed: 2026-10-13 # A Study Comparing the Pharmacokinetic Similarity of MB09 and EU/US-Sourced Xgeva NCT05299073 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05299073) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05299073) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05299073) Participants 257 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05299073) Lead sponsor mAbxience Research S.L. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05299073) Start date 2022-03-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05299073) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05299073) ## Title and summary **Summary** Randomized, double blind, parallel group, single dose, 3 arm study to investigate and compare the PK, PD, safety and immunogenicity profile of MB09 with EU/US-Xgeva® in healthy male subjects. During the course of the study, the similarity in pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms. Pharmacodynamics, safety, tolerability, and immunologic response to the administered drugs will also be evaluated throughout. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05299073) **Short title** A Study Comparing the Pharmacokinetic Similarity of MB09 and EU/US-Sourced Xgeva Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05299073) **Official title** A Randomised, Double-blind, Three-arm, Single-dose, Parallel Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity Profile of MB09 (Denosumab Biosimilar) and EU/US-sourced Xgeva® in Healthy Male Volunteers Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05299073) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05299073) **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05299073) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05299073) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05299073) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05299073) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05299073) ## Dates **Completion date** 2023-03-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05299073) **First posted** 2022-03-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05299073) **Registry last updated** 2025-01-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05299073) **Primary completion date** 2023-03-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05299073) **Start date** 2022-03-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05299073) ## Size and sites **Actual participants** 257 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05299073) **Participants** 257 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05299073) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05299073) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05299073) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05299073) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05299073) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05299073) **Lead sponsor** mAbxience Research S.L. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05299073) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05299073) ## Identifiers **Registry ID** NCT05299073 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05299073) **ClinicalTrials.gov ID** NCT05299073 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05299073) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05299073) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Triple masking **Masked roles** Participants, Care providers, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05299073) ## Outcomes ### Primary outcomes 1. AUC0-last Timeframe: Day 1 to Day 253 Area under the plasma concentration versus time curve from time zero to the last quantifiable concentration 2. Cmax Timeframe: Day 1 to Day 253 Maximum observed plasma concentration ### Secondary outcomes 1. AUC0-∞ Timeframe: Day 1 to Day 253 Area under the plasma concentration versus time curve from time zero extrapolated to infinity 2. Tmax Timeframe: Day 1 to Day 253 Time to reach Cmax 3. CL Timeframe: Day 1 to Day 253 Clearance 4. t1/2 Timeframe: Day 1 to Day 253 Terminal half-life 5. Pharmacodynamics (sCTX) AUEC0-253 Timeframe: Day 1 to Day 253 Observed concentration of serum C-terminal telopeptide of Type 1 collagen (sCTX) parameter will be calculated as PD endpoint. AUC0-253: area under the plasma concentration versus time curve from time 0 to day 253 6. Incidence of Treatment Emergent Adverse Events (TEAEs) Timeframe: Day 1 to Day 253 A treatment-emergent adverse event is defined as any event not present before exposure to study drug or any event already present that worsens in intensity or frequency after exposure. 7. Incidence of Anti-denosumab Antibodies (ADA) Timeframe: Day 1 to Day 253 The incidence of ADA to denosumab and the neutralizing potential and titre of positive ADA. The immunogenicity endpoint included denosumab anti-drug antibodies (ADA). 8. Incidence of Neutralizing Antibodies (NAb) Timeframe: Day 1 to Day 253 The incidence the neutralizing potential and titre of positive ADA. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05299073) ## Eligibility **Sex** Male **Age groups** Adults **Minimum age** 28 Years **Maximum age** 55 Years **Healthy volunteers** Yes ### Inclusion criteria 1. The subject is a male of any race, between 28 and 55 years of age, inclusive, at screening. 2. The subject has a BMI between 18.5 and 29.9 kg/m2, inclusive, (total body weight between 60 and 95 kg, inclusive) at screening and check-in. 3. The subject is considered by the investigator to be in good general health as determined by medical history, clinical laboratory test results (congenital nonhaemolytic hyperbilirubinemia \[eg, Gilbert's syndrome\] is acceptable), vital sign measurements (systolic BP ≥90 mm Hg and ≤140 mm Hg, diastolic BP ≥50 mm Hg and ≤90 mm Hg), 12 lead ECG results, and physical examination findings at screening and check in. 4. The subject must use an adequate method of contraception (eg, condom) or be willing to practice sexual abstinence during the study starting from the day of dosing and for 140 days after dosing. The subject must agree to not donating sperm during the study and for at least 140 days after dosing. Participating subject's female partner of childbearing potential should use an additional form of contraception such as an intra uterine device, barrier method with spermicide, oral contraceptive, injectable progesterone, or sub-dermal implant starting from the male partner's day of dosing until at least 140 days after dosing. The female partner of the participating subject should be familiar with the use of the respective contraceptive methods. Intra-uterine devices and hormonal methods for contraception should be used for at least 1 menstruation cycle prior to the administration of study drug. 5. The subject must be able to comprehend and willing to sign an ICF and to abide by the study restrictions. Subjects must have signed an ICF before any study-related procedure or evaluation is performed. ### Exclusion criteria 1. The subject has had previous exposure to denosumab. 2. The subject has a significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator. 3. The subject has a history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator. 4. The subject has any current or recent history of infections, including localised infections (within 2 months prior to screening for any serious infection that requires hospitalisation or IV anti-infective or within 14 days prior to screening for any active infection which requires oral treatment). 5. The subject has a dental or jaw disease requiring oral surgery or dental surgery within 6 months prior to study product administration or plans to have dental surgery within 6 months after dosing. 6. The subject has a history of osteomyelitis or osteonecrosis of the jaw requiring suturing within 30 days before dosing, or within 30 days after the last study visit. 7. The subject has a medically significant dental disease or dental neglect, with signs and/or symptoms of local or systemic infection that would likely require a dental procedure during the course of the study. Standard dentistry treatments (eg, dental filling or prophylaxis/cleaning) are allowed. 8. The subject has clinically relevant history of alcoholism, addiction or drug/chemical abuse prior to check in, and/or positive urinary test for alcohol or drugs of abuse at screening or check in. 9. The subject has positive hepatitis panel (HBV and HCV) or positive HIV test. Subjects whose results are compatible with prior immunisation and not infection may be included at the discretion of the investigator. 10. The subject has participated in a clinical study involving administration of an investigational drug (new chemical entity), with dosing in the past 90 days prior to Day 1, or within 5 half-lives of the investigational drug used in the study, whichever is longer. 11. The subject has used or intends to use slow-release medications/products considered to still be active within 30 days prior to check in, unless deemed acceptable by the investigator. 12. The subject has used or intends to use any nonprescription medications/products (except paracetamol \[up to 2 g/day\] and ibuprofen \[800 mg/day\]), including vitamins, minerals, supplements (eg, Biotin), and phytotherapeutic/herbal/plant-derived preparations within 7 days prior to check in, unless deemed acceptable by the investigator. Vitamin C, vitamin D, and calcium in daily recommended doses (≤1000 mg elemental calcium and 1000 IU vitamin D based on screening levels of vitamin D) are allowed. 13. The subject has received the COVID-19 vaccine within 14 days before Day 1 or plans to receive a COVID-19 vaccine within 12 weeks after study drug dosing or has positive test for COVID 19 during screening or presence of COVID 19 symptoms within 4 weeks prior to Day -1. 14. The subject has received a live or attenuated vaccine within 3 months prior to screening or has the intention to receive a vaccine during the study. The subject intends to travel to a region where a vaccination will be required due to endemic disease during the study. 15. The subject has used tobacco- or nicotine-containing products within 1 year prior to check-in or anytime during the study, or has a positive cotinine test upon screening or check-in. 16. The subject has donated blood within 60 days prior to dosing, plasma from 14 days prior to screening, or platelets from 42 days prior to dosing. 17. The subject has poor peripheral venous access. 18. Subjects who, in the opinion of the investigator, should not participate in this study. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05299073) ## Sites - Biokinetica - Early Phase InstituteJózefów, Poland Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05299073) ## Related records ### Drugs (2) - [Denosumab](https://trialight.com/data/asset/denosumab-9ee8731d-42aa-4d04-abbd-9dffa084523f.md) - [Ustekinumab](https://trialight.com/data/asset/ustekinumab-323cb2e2-e906-4997-ac57-d82c7f7c399d.md) ### Lead sponsors (1) - [mAbxience Research S.L.](https://trialight.com/data/company/mabxience-research-s-l-b128b627-a7c3-417d-8243-f9037e02c31d.md) ### Targets (4) - [IL12A](https://trialight.com/data/target/il12a-f7e63dfd-cd53-5ed7-ab6b-30bc302a7278.md) - [IL12B](https://trialight.com/data/target/il12b-92e53178-7b56-555c-ac6b-a1235d8fe7e5.md) - [IL23A](https://trialight.com/data/target/il23a-e11f3992-27b4-5bef-9242-07ab6ac420e9.md) - [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. 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