ACTRN12620000013965尚未招募1 期
A Randomized, Double-Blind, Parallel-Group, Single-Dose, Three-Arm Study to Compare the Pharmacokinetic Similarity of JHL1266 versus Prolia Sourced from EU and US in Healthy Human Subjects
JHL Biotech Australia Pty Ltd.0 个研究点目标入组 225 人开始时间: 2020年1月13日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 225
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 25 Years 至 55 Years（—）
- 性别
- All
入选标准
- •1. Willing and able to understand and sign an informed consent inform (ICF);
- •2. Male age between 25 to 55 years (inclusive); female age between 25 to 45 years (inclusive)
- •3. Healthy subjects (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure and pulse rate measurement, 12 lead ECG, and clinical laboratory tests);
- •4. Body Mass Index (BMI) between 18.0 and 32.0 kg per sq mtr (inclusive) ;
- •5. Weight between 50 to 100 kg (inclusive);
- •6. Men and women of childbearing age who have not undergone sterilization surgery must agree to practice effective contraception during the treatment period and within 5 months after the last administration of the study drug;
- •7. Do not smoke or smoke fewer than 5 cigarettes daily within 3 months prior to screening; do not drink or drink less than 14 units of alcohol within 6 months prior to screening (1 unit of alcohol = 360 mL beer or 45 mL spirits with 40% alcohol content or 150 mL wine).
- •8. Able to abstain from caffeine and for the duration of confinement.
排除标准
- •1. Prior diagnosis of bone disease, or any condition that will affect bone metabolism;
- •2. Osteonecrosis of the jaw (ONJ) or risk factors for ONJ such as invasive dental procedures, poor oral hygiene, periodontal, and/or pre-existing dental disease;
- •3. Past history of skin cancer;
- •4. History of recurrent skin infections or skin conditions;
- •5. Recent tooth extraction (within 6 months of screening visit);
- •6. Evidence of hypocalcaemia at screening;
- •7. Known vitamin D deficiency; or known intolerance to calcium or vitamin D supplements;
- •8. Any history of clinically serious diseases such as haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, oncologic, or allergic diseases;
- •9. Previous exposure to any monoclonal antibody or current use of any biologics for a medical condition or in the context of another clinical trial in the 6 months or 5 half-lives (whichever is longer) prior to screening;
- •10. History of allergic or anaphylactic reactions including those occurred during any clinical study or those caused by any drug or any of its excipients;
- •11. Use of prescription or non-prescription drugs and dietary supplements, within 5 half-lives of the drug or supplement, or within 2 weeks prior to taking study drug (whichever is longer), and for the duration of the study until the final follow-up visit. Herbal supplements must be discontinued 14 days prior to the administration of study drug;
- •12. Prior use of medications used for the treatment or prevention of osteoporosis or medication affecting bone turnover;
- •13. History of a blood donation within 3 months prior to the administration of study drug;
- •14. Have participated in any other clinical study within 3 months or 5 half-lives prior to the administration of study drug;
- •15. Have positive test results for hepatitis B core antibody (HBcAb), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) antibodies;
- •16. Women with a positive pregnancy test at screening or Day -1 or planning to become pregnant or lactating;
- •17. Have a history of drug abuse;
- •18. Unlikely to comply with the protocol requirements, instructions, and study related restrictions;
- •19. Subject has the presence of tattoos, sunburn, or other skin disturbances on both the left and right upper arm which may interfere with a medical assessment of the injection site.
研究者
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