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

NCT ID: NCT06310824

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 225 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-05
• Study Completion Date: 2025-07-22

Brief Summary

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.

Conditions

Healthy Participants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

MAB-22

Single subcutaneous injection on Day 1

Group Type: EXPERIMENTAL

MAB-22

Intervention Type: DRUG

60mg dose of a single subcutaneous injection

EU-Prolia®

Single subcutaneous injection on Day 1

Group Type: ACTIVE_COMPARATOR

EU-Prolia®

Intervention Type: DRUG

60mg dose of a single subcutaneous injection

US-Prolia®

Single subcutaneous injection on Day 1

Group Type: ACTIVE_COMPARATOR

US-Prolia®

Intervention Type: DRUG

60mg dose of a single subcutaneous injection

Interventions

MAB-22

60mg dose of a single subcutaneous injection

Intervention Type: DRUG

EU-Prolia®

60mg dose of a single subcutaneous injection

Intervention Type: DRUG

US-Prolia®

60mg dose of a single subcutaneous injection

Intervention Type: DRUG

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Xentria, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xentria Investigative Site

Budapest, , Hungary

Xentria Investigative Site

Groningen, , Netherlands

Countries

Hungary; Netherlands

Other Identifiers

MAB-22-101

Identifier Type: -

Identifier Source: org_study_id