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

NCT06310824 | Completed Phase 1 FDA Drug

• 1 other identifier: MAB-22-101
• Study Type: interventional
• Target: 225
• Locations: 2 countries
• Sites: 2

Brief Summary

A Randomized, Double-blind, Controlled, Parallel-group, Single Dose, Three-arm Study to Compare the Pharmacokinetic Similarity of MAB-22 Versus Prolia®

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  Day 1 to Week 37

Secondary Outcomes (3)

• Area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC0-last)

  Day 1 to Week 37

• Area under the concentration-time curve

  0 to Week 21

• Area under the concentration-time curve

  Week 21 to Week 37

Study Arms (3)

MAB-22

EXPERIMENTAL

Single subcutaneous injection on Day 1

Drug: MAB-22

EU-Prolia®

ACTIVE COMPARATOR

Single subcutaneous injection on Day 1

Drug: EU-Prolia®

US-Prolia®

ACTIVE COMPARATOR

Single subcutaneous injection on Day 1

Drug: US-Prolia®

Interventions

MAB-22 DRUG

60mg dose of a single subcutaneous injection

MAB-22

EU-Prolia® DRUG

60mg dose of a single subcutaneous injection

EU-Prolia®

US-Prolia® DRUG

60mg dose of a single subcutaneous injection

US-Prolia®

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xentria, Inc.: lead

Study Sites (2)

Xentria Investigative Site

Budapest, 1077, Hungary

Location

Xentria Investigative Site

Groningen, 9728 NZ, Netherlands

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 15, 2024
• Study Start: June 5, 2024
• Primary Completion: July 22, 2025
• Study Completion: July 22, 2025
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1); NL (1)