Clinical trial NCT06310824: Single Dose, Three-arm Study to Compare the Pharmacokinetic Similarity of MAB-22 Versus Prolia®
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Xentria, Inc.
Sponsor class: INDUSTRY
First posted: 2024-03-15
Enrollment: 225
Sex: MALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-∞)
timeFrame: Day 1 to Week 37
measure: Maximum observed serum concentration (Cmax)
timeFrame: Day 1 to Week 37
Secondary outcomes:
measure: Area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC0-last)
timeFrame: Day 1 to Week 37
measure: Area under the concentration-time curve
timeFrame: 0 to Week 21
measure: Area under the concentration-time curve
timeFrame: Week 21 to Week 37
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Xentria Investigative Site
city: Groningen
country: Netherlands
facility: Xentria Investigative Site
Study officials:
References: