> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/single-dose-three-arm-study-to-compare-the-pharmacokinetic-ff7b9a2b-ba16-4d1c-82d6-8cd68801853b > Record changed: 2026-10-13 # Single Dose, Three-arm Study to Compare the Pharmacokinetic Similarity of MAB-22 Versus Prolia® NCT06310824 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06310824) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06310824) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06310824) Participants 225 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06310824) Lead sponsor Xentria, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06310824) Start date 2024-06-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06310824) Number of sites 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06310824) ## Title and summary **Summary** A Randomized, Double-blind, Controlled, Parallel-group, Single Dose, Three-arm Study to Compare the Pharmacokinetic Similarity of MAB-22 Versus Prolia® Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06310824) **Short title** Single Dose, Three-arm Study to Compare the Pharmacokinetic Similarity of MAB-22 Versus Prolia® Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06310824) **Official title** A Randomized, Double-blind, Controlled, Parallel-group, Single Dose, Three-arm Study to Compare the Pharmacokinetic Similarity of MAB-22 Versus Prolia® Sourced From the European Union and United States in Healthy Male Participants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06310824) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06310824) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06310824) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06310824) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06310824) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06310824) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06310824) ## Dates **Completion date** 2025-07-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06310824) **First posted** 2024-03-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06310824) **Registry last updated** 2025-07-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06310824) **Primary completion date** 2025-07-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06310824) **Start date** 2024-06-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06310824) ## Size and sites **Actual participants** 225 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06310824) **Participants** 225 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06310824) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06310824) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06310824) **Number of sites** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06310824) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06310824) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06310824) **Lead sponsor** Xentria, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06310824) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06310824) ## Identifiers **Registry ID** NCT06310824 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06310824) **ClinicalTrials.gov ID** NCT06310824 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06310824) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06310824) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Other **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06310824) ## Outcomes ### Primary outcomes 1. Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-∞) Timeframe: Day 1 to Week 37 Primary endpoints are to compare Pharmacokinetics (PK) similarity in healthy male participants assessments collected during predose and postdose (Day 1) at 4 and 24 hours, and at Days 3, 7, 11, 15, 22, 29, 43, 57, 71, 85, 113, 141, 169, 197, 225, and 253\. PK and Pharmacodynamic (PD) 2. Maximum observed serum concentration (Cmax) Timeframe: Day 1 to Week 37 Primary endpoints are to compare Pharmacokinetics (PK) similarity in healthy male participants assessments collected during predose and postdose (Day 1) at 4 and 24 hours, and at Days 3, 7, 11, 15, 22, 29, 43, 57, 71, 85, 113, 141, 169, 197, 225, and 253\. PK and Pharmacodynamic (PD) ### Secondary outcomes 1. Area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC0-last) Timeframe: Day 1 to Week 37 Secondary endpoints are to assess the safety, tolerability, Pharmacokinetics (PK) and Pharmacodynamic (PD), and immunogenicity of MAB-22 versus Prolia® (US-licensed) and Prolia® (EU-approved) in healthy participants assessments collected during predose and postdose (Day 1) at 4 and 24 hours, and at Days 3, 7, 11, 15, 22, 29, 43, 57, 71, 85, 113, 141, 169, 197, 225, and 253. 2. Area under the concentration-time curve Timeframe: 0 to Week 21 Secondary endpoints are to assess the safety, tolerability, Pharmacokinetics (PK) and Pharmacodynamic (PD), and immunogenicity of MAB-22 versus Prolia® (US-licensed) and Prolia® (EU-approved) in healthy participants assessments collected during predose and postdose (Day 1) at 4 and 24 hours, and at Days 3, 7, 11, 15, 22, 29, 43, 57, 71, 85, 113, 141, 169, 197, 225, and 253. 3. Area under the concentration-time curve Timeframe: Week 21 to Week 37 Secondary endpoints are to assess the safety, tolerability, Pharmacokinetics (PK) and Pharmacodynamic (PD), and immunogenicity of MAB-22 versus Prolia® (US-licensed) and Prolia® (EU-approved) in healthy participants assessments collected during predose and postdose (Day 1) at 4 and 24 hours, and at Days 3, 7, 11, 15, 22, 29, 43, 57, 71, 85, 113, 141, 169, 197, 225, and 253. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06310824) ## Eligibility **Sex** Male **Age groups** Adults **Minimum age** 25 Years **Maximum age** 55 Years **Healthy volunteers** Yes ### Inclusion criteria 1. Healthy male participants between 25 and 55 years of age (inclusive) on the day of signing the informed consent. 2. Have a body weight between 50.0 and 110.0 kg (inclusive) and a body mass index (BMI) between 18.0 and 32.9 kg/m2 (inclusive). 3. Have 12-lead electrocardiogram (ECG) results without clinically significant abnormal findings confirmed by the investigator. 4. Have vital sign results without clinically significant abnormal findings confirmed by the investigator, including but not limited to: 1. Resting supine systolic blood pressure <145 mmHg and diastolic blood pressure of <90 mmHg. 2. Heart rate 40 to 100 beats per minute (bpm). 3. Respiration rate 8 to 20 resp/min. 4. Temporal or ear temperature 35.5 to 37.6°C. 5. Oxygen saturation 95 to 100%. 5. Have physical examination results without clinically significant abnormal findings confirmed by the investigator. ### Exclusion criteria 1. Prior diagnosis of bone disease, or any condition that will affect bone metabolism such as, but not limited to: osteoporosis, osteogenesis imperfecta, hyperparathyroidism, hyperthyroidism, hypothyroidism, osteomalacia, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, current flare-up of osteoarthritis and/or gout, active malignancy, moderate to severe renal disease (defined as glomerular filtration rate <60 mL/min), Paget's disease of the bone, recent bone fracture (within 6 months), or malabsorption syndrome. 2. Osteonecrosis of the jaw (ONJ) or risk factors for ONJ, such as invasive dental procedures (e.g., tooth extraction, dental implants, oral surgery in the past 6 months), poor oral hygiene, periodontal, and/or preexisting dental disease at the determination of the investigator. 3. Recent tooth extraction (within 6 months of the screening visit). Edentulous participants are permitted to enroll in the study, as long as the most recent tooth extraction occurred >6 months prior to the screening visit. 4. Evidence of hypocalcemia (total calcium below the normal range \[8.5 to 10.5 mg/dL or 2.21 to 2.65 mmol/L\]) at screening. 5. Known vitamin D deficiency (defined as vitamin D <12 ng/mL or <30.0 nmol/L); or known intolerance to calcium or vitamin D supplements. Retest of vitamin D is allowed once. Vitamin D repletion is permitted (e.g., vitamin D supplements) with a tolerable upper intake level of 100 mcg (4000 IU) daily, at the discretion of the investigator. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06310824) ## Sites - Xentria Investigative SiteBudapest, Hungary - Xentria Investigative SiteGroningen, Netherlands Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06310824) ## Related records ### Drugs (1) - [Denosumab](https://trialight.com/data/asset/denosumab-9ee8731d-42aa-4d04-abbd-9dffa084523f.md) ### Lead sponsors (1) - [Xentria, Inc.](https://trialight.com/data/company/xentria-inc-913b13c1-f460-43b2-80ee-b4997abfea11.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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