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
- Conditions
- 10023213osteoarthritispain
- Registration Number
- NL-OMON35149
- Lead Sponsor
- Abbott B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 56
• • 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
• 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Firstly, we will investigate the safety and tolerability of the study drug<br /><br>following administration of a single escalating dose of the drug. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondly, we will investigate the rate at which the study drug is absorbed into<br /><br>the body. Thirdly, we will investigate whether the body develops antibodies to<br /><br>the study drug (this is known as *immunogenicity*). Lastly, we will investigate<br /><br>the effect of the study drug on the body.</p><br>