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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- Maximum observed serum concentration (Cmax)
研究概览
简要总结
A Randomized, Double-blind, Controlled, Parallel-group, Single Dose, Three-arm Study to Compare the Pharmacokinetic Similarity of MAB-22 Versus Prolia®
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
EU-Prolia®
Single subcutaneous injection on Day 1
干预措施: EU-Prolia® (Drug)
US-Prolia®
Single subcutaneous injection on Day 1
干预措施: US-Prolia® (Drug)
MAB-22
Single subcutaneous injection on Day 1
干预措施: MAB-22 (Drug)
结局指标
主要结局
Maximum observed serum concentration (Cmax)
时间窗: Day 1 to Week 37
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)
Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-∞)
时间窗: Day 1 to Week 37
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)
次要结局
- 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(Week 21 to Week 37)