NL-OMON46705已完成不适用
A randomized, placebo controlled, subject and investigator blinded, first-in-human, single ascending dose study to evaluate the safety, tolerability, and pharmacokinetics after intra-articular injection of LRX712 into the knee of osteoarthritic patients. - Safety, tolerability, and pharmacokinetics of LRX712
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 42
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
- 年龄范围
- 18 至 64（—）
入选标准
- •Moderate knee OA patients eligible for inclusion in this study must fulfill all of the following
- •1. Subjects must sign a written informed consent before any assessment is performed.
- •2. Male and female patients 35 to 65 years of age inclusive, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
- •3. At screening, and at baseline vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the sitting position after the subject has rested for at least three minutes, and again (when required) after three minutes in the standing position as outlined in the SOM. Sitting vital signs should be guided by the following ranges: Oral body temperature between 35.0-37.5 °C, systolic blood pressure 90-139 mm Hg, diastolic blood pressure 50-89 mm Hg, pulse rate 40 - 90 bpm
- •4. Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 32 kg/m2. BMI <= Body weight (kg) / [Height (m)]
- •5. Able to communicate well with the investigator, to understand and comply with the requirements of the study.
- •6. Patient has radiologically apparent moderate degenerative joint disease in the target knee as determined by Kellgren and Lawrence grade 1- 3 based on X-ray evaluation performed within 6 months from screening.
排除标准
- •Moderate knee OA patients fulfilling any of the following criteria are not eligible for inclusion in this study:
- •1. Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days, whichever is longer; or longer if required by local regulations.
- •2. History of hypersensitivity to any of the study treatments or excipients or to drugs of similar chemical classes.
- •3. A history of clinically significant ECG abnormalities, or any of the following ECG abnormalities at screening and baseline:
- •* PR > 200 msec
- •* QRS complex > 120 msec
- •* QTcF > 450 msec (males)
- •* QTcF > 460 msec (females)
- •4. Known family history or known presence of long QT syndrome.
- •5. Known history or current clinically significant arrhythmias.
- •6. Concomitant use of agents known to prolong the QT interval unless they can be permanently discontinued for the duration of study.
- •7. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- •8. Pregnant or nursing (lactating) women.
- •9. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.
- •10. Sexually active males unwilling to use a condom during intercourse for five times the T* of LRX712 after drug administration. A condom is required for all sexually active male participants to prevent them from fathering a child AND to prevent delivery of the investigational drug via seminal fluid to their partner. In addition, male participants should not donate sperm for the time period specified above.
- •11. Use of any strong CYP3A4 inhibitors or inducers from screening to end of study. These drugs can be used if they are the only appropriate treatment in case of urgent medical intervention, and must be documented in the Concomitant medications / Significant non-drug therapies page of the CRF.
- •12. Donation or loss of 450 mL or more of blood within eight weeks prior to initial dosing, or longer if required by local regulation.
- •13. Hemoglobin levels below 12.0 g/dL at screening or baseline.
- •14. Significant illness which has not resolved within two (2) weeks prior to initial dosing.
- •15. Recent (within the last three years) and/or recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc.).
- •16. Recent (within the last three years) and/or recurrent history of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
- •17. History of multiple and recurring allergies or allergy to the investigational compound/compound class being used in this study.
- •18. History of immunodeficiency diseases, or a positive HIV (ELISA and Western blot) test result.
研究者
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