Comparing the effects of MAB-22 and Prolia® in healthy men

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

This study is testing a new bone health medication called MAB-22 in healthy men to see how it compares to Prolia® in terms of safety and how the body processes it.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 225 (estimated)
• Ages: 25 Years to 55 Years
• Sex: Male
• Sponsor: Xentria, Inc. (Industry-sponsored)
• Locations: 2 sites (Budapest and 1 other locations)
• Trial ID: NCT06310824 on ClinicalTrials.gov

What this trial studies

This Phase 1 clinical trial is a randomized, double-blind, controlled study designed to evaluate the pharmacokinetic similarity between MAB-22 and Prolia®, a medication used for bone health. The study involves healthy male participants aged 25 to 55 who will receive a single subcutaneous injection of either MAB-22, EU-Prolia®, or US-Prolia®. The trial aims to assess various factors including safety, tolerability, and immunogenicity of MAB-22 compared to Prolia®.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy male participants aged 25 to 55 with specific weight and BMI criteria.

Not a fit: Patients with prior diagnoses of bone disease or other significant health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new biosimilar treatment option for patients requiring bone health management.

How similar studies have performed: While this study is assessing a biosimilar, similar studies have shown promise in establishing the safety and efficacy of biosimilars in other therapeutic areas.

Eligibility criteria

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.

Where this trial is running

Budapest and 1 other locations

• Xentria Investigative Site — Budapest, Hungary (Recruiting)
• Xentria Investigative Site — Groningen, Netherlands (Recruiting)

Study contacts

• Study coordinator: Xentria Inc. Xentria Inc.

Conditions Healthy Participants