Healthy ParticipantsPhase 1NCT06310824
Single Dose, Three-arm Study to Compare the Pharmacokinetic Similarity of MAB-22 Versus Prolia®
A Phase 1 study testing MAB-22, EU-Prolia® and US-Prolia® in people with Healthy Participants, run by Xentria, Inc. at 2 sites in 2 countries.
Trial summary
A Randomized, Double-blind, Controlled, Parallel-group, Single Dose, Three-arm Study to Compare the Pharmacokinetic Similarity of MAB-22 Versus Prolia® Read more about this study
- Who is it for?
- Ages 25 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- MAB-22, EU-Prolia® and US-Prolia®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 5 Jun 2024to 22 Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male participants between 25 and 55 years of age (inclusive) on the day of signing the informed consent.
- 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).
- Have 12-lead electrocardiogram (ECG) results without clinically significant abnormal findings confirmed by the investigator.
- Have vital sign results without clinically significant abnormal findings confirmed by the investigator, including but not limited to:
- Resting supine systolic blood pressure <145 mmHg and diastolic blood pressure of <90 mmHg.
- Heart rate 40 to 100 beats per minute (bpm).
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- Respiration rate 8 to 20 resp/min.
- Temporal or ear temperature 35.5 to 37.6°C.
- Oxygen saturation 95 to 100%.
- Have physical examination results without clinically significant abnormal findings confirmed by the investigator.
Who cannot join
- 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.
- 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.
- 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.
- 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.
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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
A Randomized, Double-blind, Controlled, Parallel-group, Single Dose, Three-arm Study to Compare the Pharmacokinetic Similarity of MAB-22 Versus Prolia®
Read the detailed description
This study is a Phase 1, double-blind, randomized, single dose, parallel-group, 3-arm, Pharmacokinetic (PK) study designed to assess the biosimilarity, including the PK, Pharmacodynamics (PD), safety, tolerability, and immunogenicity of MAB-22 compared with reference Prolia® sourced from the European Union (EU) and United States (US) after single subcutaneous (SC) injection in healthy male participants.
- Conditions
- Healthy Participants
- Being tested
- MAB-22, EU-Prolia®, US-Prolia®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAB-22Drug
60mg dose of a single subcutaneous injection
EU-Prolia®Drug
60mg dose of a single subcutaneous injection
US-Prolia®Drug
60mg dose of a single subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| MAB-22 | Experimental | Single subcutaneous injection on Day 1 Receives: Drug: MAB-22 |
| EU-Prolia® | Active comparator | Single subcutaneous injection on Day 1 Receives: Drug: EU-Prolia® |
| US-Prolia® | Active comparator | Single subcutaneous injection on Day 1 Receives: Drug: US-Prolia® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-∞)
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)
Measured: Day 1 to Week 37
Maximum observed serum concentration (Cmax)
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)
Measured: Day 1 to Week 37
Secondary outcomes (3)
Area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC0-last)
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.
Measured: Day 1 to Week 37
Area under the concentration-time curve
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.
Measured: 0 to Week 21
Area under the concentration-time curve
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.
Measured: Week 21 to Week 37
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start5 Jun 2024
- Primary completion22 Jul 2025
- Study completion22 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xentria, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06310824
- Sponsor's protocol ID
- MAB-22-101
- Status last verified
- Jul 2025
- First submitted
- 29 Feb 2024
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06310824
- Acronym / sponsor ID
- MAB-22-101
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Xentria, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Jun 2024 (actual)
- Primary completion
- 22 Jul 2025 (actual)
- Study completion
- 22 Jul 2025 (actual)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Randomized, Double-blind, Controlled, Parallel-group, Single Dose, Three-arm Study to Compare the Pharmacokinetic Similarity of MAB-22 Versus Prolia®
Detailed description
This study is a Phase 1, double-blind, randomized, single dose, parallel-group, 3-arm, Pharmacokinetic (PK) study designed to assess the biosimilarity, including the PK, Pharmacodynamics (PD), safety, tolerability, and immunogenicity of MAB-22 compared with reference Prolia® sourced from the European Union (EU) and United States (US) after single subcutaneous (SC) injection in healthy male participants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MAB-22 | Experimental | Drug: MAB-22Single subcutaneous injection on Day 1 |
| EU-Prolia® | Active comparator | Drug: EU-Prolia®Single subcutaneous injection on Day 1 |
| US-Prolia® | Active comparator | Drug: US-Prolia®Single subcutaneous injection on Day 1 |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy male participants between 25 and 55 years of age (inclusive) on the day of signing the informed consent.
- 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).
- Have 12-lead electrocardiogram (ECG) results without clinically significant abnormal findings confirmed by the investigator.
- Have vital sign results without clinically significant abnormal findings confirmed by the investigator, including but not limited to:
- Have physical examination results without clinically significant abnormal findings confirmed by the investigator.
Key exclusion criteria (5 listed)
- 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.
- 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.
- 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.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAB-2260mg dose of a single subcutaneous injection | Drug | MAB-22 |
| EU-Prolia®60mg dose of a single subcutaneous injection | Drug | EU-Prolia® |
| US-Prolia®60mg dose of a single subcutaneous injection | Drug | US-Prolia® |
Primary outcome
Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-∞)
Time frame: 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)
Maximum observed serum concentration (Cmax)
Time frame: 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)
3 secondary outcomes
Area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC0-last)
Time frame: Day 1 to Week 37
Area under the concentration-time curve
Time frame: 0 to Week 21
Area under the concentration-time curve
Time frame: Week 21 to Week 37
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MAB-22, EU-Prolia® and US-Prolia® in people with Healthy Participants, run by Xentria, Inc. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hungary, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-∞) (time frame: Day 1 to Week 37). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025; AzTrials last refreshed its copy on 26 Oct 2026.