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

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06310824
• Other study ID #: MAB-22-101
• Status: Recruiting
• Phase: Phase 1
• Start date: June 5, 2024
• Est. completion date: July 2025

Study information

• Verified date: June 2024
• Source: Xentria, Inc.
• Contact: Xentria Inc. Xentria Inc.
• Phone: 2244434615
• Email: info[@]xentria.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• MAB-22
60mg dose of a single subcutaneous injection
• EU-Prolia®
60mg dose of a single subcutaneous injection
• US-Prolia®
60mg dose of a single subcutaneous injection

Locations

Country	Name	City	State
Hungary	Xentria Investigative Site	Budapest
Netherlands	Xentria Investigative Site	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Xentria, Inc.

Countries where clinical trial is conducted

Hungary,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-8)	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
Primary	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	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.	Day 1 to Week 37
Secondary	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.	0 to Week 21
Secondary	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.	Week 21 to Week 37