CTRI/2024/02/063265招募中1 期
A Randomized, Double-blind, Two-arm, Single-dose, Parallel Group Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Bmab 1000 and EU-approved Xgeva® in Normal Healthy Male Volunteers - NI
试验速览
- 阶段
- 1 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Gender: Male
- •2.Age: 28-55 years, both inclusive, at screening
- •3.Weight: 50.0-95.0 kg, both inclusive, at screening
- •4.Body mass index between 18.0 kg/m2 and 30.0 kg/m2, both inclusive, at screening
- •5.Willingness to participate in the 9-month study and follow all study-related procedures/restrictions by signing or providing thumb impression on the written informed consent form
- •6.Resting supine systolic blood pressure (SBP) of <140/ >90 mmHg and diastolic blood pressure of <90/ >60 mmHg. Other vital signs showing no clinically relevant deviations in the Principal Investigator’s (PI’s) judgment.
- •7.12-lead ECG recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the PI
- •8.Ability and willingness to abstain from alcohol from 48 hrs prior to drug administration and 48 hrs prior to ambulatory visits, and during the stays in the clinical research center until discharge from the in-house period
- •9.Fertile males participating in heterosexual relations: willingness to use adequate contraception (i.e., two effective methods, one of which must be a physical barrier method) from screening until 36 weeks after dosing or must be sexually inactive by abstinence, which is consistent with the preferred and usual lifestyle of the subject.
- •Note: Effective forms of contraception are a condom, an established form of hormonal contraception, a diaphragm or cervical/vault cap, or an intrauterine device. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Sterile men, and subjects who have same-sex sexual relations, do not have to use contraception
- •10.White blood cells, platelet count, hemoglobin, other hematology, and biochemistry tests of blood and urine within the reference ranges of the safety laboratory. Minor deviations considered to lack any clinical relevance by the PI can be accepted.
排除标准
- •1.Any past or concurrent medical conditions potentially increasing the subject’s risks during participation in the study. Examples of these include medical history with evidence of clinically relevant pathology (e.g., malignancies, demyelinating disorders)
- •2.Unable to follow protocol instructions in the opinion of the PI
- •3. History of relevant drug and/or food allergies (including hypersensitivity to any recombinant protein drug, latex, or any of the constituents of Bmab 1000/Xgeva)
- •4.Known history of exposure to denosumab (even in trial setting)
- •5.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, renal disease (defined as glomerular filtration rate <60 mL/min), Paget’s disease of the bone, recent bone fracture (within 6 months), malabsorption syndrome
- •6.Any prior use of bone-modifying medications. This includes medications such as, but not limited to, bisphosphonates, fluoride, calcitonin, strontium, parathyroid hormone or derivatives, anabolic steroids, calcitriol, diuretics, over the counter medications, herbal supplements within the last 3 months before screening
- •7.Use of systemic glucocorticosteroids (=5 mg prednisone equivalent per day for =10 days) within the past 3 months before screening. Topical and nasal corticosteroids will be allowed
- •8.Any current active infections, including localized infections, or any recent history of active infections, cough, or fever, or a history of recurrent or chronic infections that require systemic antibiotic therapy (within 1 week prior to study drug administration)
- •9.Treatment with non-topical medications (including over the counter medication and herbal remedies such as St. John’s Wort extract) within 7 days prior to study drug administration, with the exception of topical medications, multivitamins, Vitamin C, Vitamin D, calcium, food supplements, and a limited amount of acetaminophen, which can be used throughout the study
- •10.Personal/family history suggestive of prolonged QT interval syndrome or family history of sudden death
- •11.Having received live vaccines during the 4 weeks prior to study drug administration or has the intention to receive live vaccination during the study
- •12.Have previously been exposed to a monoclonal antibody or fusion protein (other than denosumab) within 270 days (or five half-lives, whichever is the longest) prior to randomization and/or there is clinical suspicion or confirmed evidence of immunogenicity from previous exposure to a monoclonal antibody or fusion protein
- •13.Have previously been exposed to an immunosuppressive agent or biological agent (other than a monoclonal antibody or fusion protein) within 120 days (or five half-lives, whichever is the longest) prior to randomization, except COVID-19 vaccine
- •14.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 pre-existing dental disease as judged by the PI
- •15.Participant having Vitamin D total deficiency
- •16.Current hypocalcemia
研究者
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