CompletedNCT06310824Updated Jul 29, 2025

Single Dose, Three-arm Study to Compare the Pharmacokinetic Similarity of MAB-22 Versus Prolia®

A Phase 1 interventional study of MAB-22 and EU-Prolia® in Healthy Participants, sponsored by Xentria, Inc.. Completed at 2 sites in 2 countries. Open to male participants aged 25 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-29.

Sponsored by Xentria, Inc. · Phase 1, Interventional, and Other

Phase: Phase 1
Study type: Interventional
Enrollment: 225
Allocation: Randomized
Ages: 25 Years to 55 Years
Sex: Male

Study summary

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 studied

Healthy Participants

Who can participate

Ages eligible: 25 Years to 55 Years
Sexes eligible: Male
Accepts healthy volunteers: Yes

Inclusion criteria

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:
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%.
Have physical examination results without clinically significant abnormal findings confirmed by the investigator.

Exclusion criteria

Exclusion Criteria:

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.

Study design

Phase: Phase 1
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 225 participants (actual)

Study arms

Experimental
MAB-22
Single subcutaneous injection on Day 1
Drug: MAB-22
Active comparator
EU-Prolia®
Single subcutaneous injection on Day 1
Drug: EU-Prolia®
Active comparator
US-Prolia®
Single subcutaneous injection on Day 1
Drug: US-Prolia®

Interventions

DrugMAB-22
60mg dose of a single subcutaneous injection
DrugEU-Prolia®
60mg dose of a single subcutaneous injection
DrugUS-Prolia®
60mg dose of a single subcutaneous injection

What researchers measure

Primary outcomes

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)
Time frame: 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)
Time frame: Day 1 to Week 37

Secondary outcomes

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.
Time frame: 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.
Time frame: 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.
Time frame: Week 21 to Week 37

Study locations

2 sites

Xentria Investigative Site
Budapest, 1077, Hungary
Xentria Investigative Site
Groningen, 9728 NZ, Netherlands

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT06310824
Lead sponsor: Xentria, Inc.
Responsible party: Sponsor
First posted: Mar 15, 2024
Start date: Jun 5, 2024
Primary completion: Jul 22, 2025
Completion: Jul 22, 2025
Last update: Jul 29, 2025

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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