NL-OMON35149已完成不适用
A randomised, double-blind, placebo-controlled, single ascending dose, Phase I study to evaluate the safety, tolerability, and pharmacokinetics of PG110 (anti-NGF monoclonal antibody) in patients with pain attributed to osteoarthritis of the knee - Safety and tolerability of PG110 in patients with knee osteoarthritis pain
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Abbott B.V.
- 入组人数
- 56
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 99（—）
入选标准
- •• you have given your written consent to take part in this study;
- •you are between 18 and 75 years of age;
- •you are in good physical and mental health;
- •your body weight must be appropriate in relation to your height (between 50 and 110 kg);
- •for female volunteers: you are not pregnant, nor can you get pregnant (you are surgically sterile or your uterus has been removed or you have been post-menopausal - if you are over 50 years old, your last menstrual period must be at least one year ago; if you are 50 years or younger, your last menstrual period must be more than two years ago);
- •you are suffering from pain due to osteoarthritis of the knee;
- •no abnormalities are diagnosed during the screening;
- •Kellgren-Lawrence grade 2, 3 or 4 upon radiographic examination of the index knee
排除标准
- •you are (or have been) taking illegal drugs and/or are (or have been) using alcohol to excess;
- •you drink more than 21 units of alcohol per week;
- •you have had an operation during the past 6 months or you are planning to undergo an operation less than 6 months after administration of the study drug;
- •you have taken part in another clinical drug study during the last 3 months prior to the study;
- •you have donated blood during the last three months prior to the study;
- •you have hepatitis B or C or are HIV positive;
- •the study physician is of the opinion that you are not suitable for participation in this study;
- •you have clinically significant knee abnormalities which render you unsuitable for this study;
- •you are in so much pain that you cannot adhere to the medication restrictions as described in the Information Sheet on Study Restrictions (SF3131);
- •you cannot adhere to the contraceptive methods as described in the Information Sheet on Contraceptive Rules (SF1032);
- •you are bedridden or you are in a wheelchair;
- •you have had keyhole surgery of the knee during the last 6 months prior to the study;
- •you are planning to lose weight or to change your normal pattern of physical activity (your eating habits and your pattern of physical activity must be stable);
- •you have chronic pain due to fibromyalgia;
- •you are suffering from a mental disorder;
- •you have a neurological condition;
- •you faint regularly;
- •your memory is impaired;
- •you are suffering from a clinically significant cardiovascular disorder;
- •you have cancer or have had cancer in the past;
- •you have a relevant drug allergy or you are hypersensitive to medication;
- •you have clinically relevant abnormalities in the opinion of the PI in serum chemistry, hematology and urinalysis.
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