ACTRN12620000782932招募中1 期
A Phase 1b, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Multiple Subcutaneous Doses of OLP-1002 in Patients Who Have Pain due to Moderate to Severe Osteoarthritis in a Hip and/or Knee joint
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
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
- 35 Years 至 65 Years（—）
- 性别
- All
入选标准
- •1.Male or female aged greater than or equal to 35 years to lesser than or equal to 65 years as of the date of study enrolment;
- •2.Patients must be willing and able to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures;
- •3.Patients have a BMI greater than or equal to 18 and less than 40 kg/m2 at Screening;
- •4.Patients have pain in (a) hip or knee joint/s, every day for at least one month during the three months prior to Screening;
- •5.Patients have a diagnosis of moderate to severe OA of the index hip or knee: moderate to severe osteoarthritis, based on American College of Rheumatology (ACR) criteria with Kellgren Lawrence x-ray grade of at least 3 as diagnosed by the radiologist;
- •6.Patients with WOMAC Total Pain subscale score of equal to 10 in the index hip or knee at Screening;
- •7.Patients who are willing to discontinue all non-study pain medications except for permitted rescue pain medication for the duration of the study;
- •8.Patients agree to maintain their usual levels of activity throughout the course of the study and until End of Study (EOS) (Day 45);
- •9.Patients who are willing to abstain from all other intra-articular treatments of the joint and any joint surgery while in the study and until EOS (Day 45);
- •10.Patients having clear injection sites, although parts of the body have tattoos;
- •11.Patients who are willing and able to comply with study procedures, including the recording of daily questionnaires;
- •12.Females must be non-pregnant and non-lactating, and must use acceptable, highly effective double contraception from screening until 90 days after the last dose of study drug. Double contraception is defined as a condom AND one other form of the following:
- •a.Established hormonal contraception (for example, approved oral contraceptive pills (OCPs), long-acting implantable hormones, injectable hormones);
- •b.A vaginal ring or an intrauterine device (IUD); or
- •c.Documented evidence of surgical sterilisation at least 6 months prior to screening (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy for women or vasectomy for men [with appropriate post-vasectomy documentation of the absence of sperm in semen] provided the male partner is a sole partner)
- •d.Women not of childbearing potential must be post menopausal for equal to 12 months. Post-menopausal status will be confirmed through testing of follicle-stimulating hormone (FSH) levels equal to 40 IU/mL at Screening for amenorrhoeic female patients. Females who are abstinent from heterosexual intercourse will also be eligible.
- •e.Periodic abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods) and withdrawal are not considered highly effective methods of birth control. A patient’s complete abstinence for the duration of the study and for 90 days after the last study treatment is acceptable.
- •f.Female patients who are in a same-sex relationships are not required to use contraception.
- •g.Males must be surgically sterile (greater than 30 days since vasectomy with no viable sperm), abstinent, or if engaged in sexual relations with a women of child bearing potential (WOCBP), the patient and his partner must be surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or using an acceptable, highly effective contraceptive method from Screening until 90 days after the last dose
排除标准
- •1.Any of the following:
- •QTcF greater than 450 ms confirmed by repeat ECG measurement
- •QRS duration greater than 110 ms confirmed by repeat ECG measurement
- •PR interval greater than 220 ms confirmed by repeat ECG measurement
- •Findings which would make QTc measurements difficult or QTcF data uninterpretable
- •History of additional risk factors for torsades de pointes (e.g., heart failure (class III/IV according to the New York Heart Association [NYHA]), hypokalaemia, family history of long QT syndrome)
- •2.Intraarticular treatment injections (including but not limited to corticosteroids, hyaluronic acid, platelet rich plasma, BOTOX®, local anaesthetics) within 3 months prior to the Screening period
- •3.Patients who are unable or unwilling to cease the use of all pain medications, prescription, over-the-counter and otherwise, as of the first day of the study Washout Period and until after Day 45 of the study. This includes all opioid and anti-inflammatory medications. This excludes the use of paracetamol provided that a patient is able and willing to utilise a maximum of 2 g of paracetamol per 24-hour period as of the first day of the study Washout Period and until after Day 45 of the study, unless the PI has approved an increased dose up to 4 g;
- •4.Use or intend to use TENS machine during the study period, i.e. from screening until after Day 45 of the study;
- •5.Any of the following laboratory abnormalities within14 days of the first treatment day:
- •Platelet count less than 100,000 cells/mm3
- •Total neutrophil count less than 1500 cells/mm3
- •Serum creatinine greater than or equal to 1.5 x ULN
- •Alanine aminotransferase (ALT) greater than 3.0 x ULN
- •Aspartate aminotransferase (AST) greater than 3.0 x ULN
- •Alkaline phosphatase greater than 2.0 x ULN
- •Bilirubin greater than 1.5 x ULN
- •Temperature greater than or equal to 38°C or any other evidence of an infection
- •6.History of alcohol or substance abuse or dependence during the 12 months prior to Screening
- •During the study, alcohol consumption of greater than 21 units per week for males and greater than14 units per week for females will not be allowed. One unit of alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1/6 gill (25 mL) of spirits;
- •Positive urine drug screen (confirmed by repeat) or alcohol consumption (self-report) higher than the permissible limit, as mentioned above, within the preceding 3 days at Screening or Baseline shall be excluded from the study;
- •7.Use or intend to use medication that interacts with CYP3A4 and/or CYP2D6, see Section 9.4.1 on restricted medication ;
- •8.Has an allergy or hypersensitivity to the study drug or its components;
- •9.Female patients who are pregnant at Screening or are planning on becoming pregnant, or are currently breastfeeding;
- •10.Patients with any medical condition or comorbidities that could adversely impact study participation or safety, conduct of the study, or interfere with pain assessments;
- •11.Active skin conditions such as dermatitis, allergy, eczema, psoriasis, or abnormal skin healing in any body area;
- •12.Patients who have tattoos, scars, or moles that in the opinion of the Investigator are likely to interfere with dosing or study assessments at any of the potential injection sites;
- •13.Depression of moderate severity or more on the Patient Health Questionnaire (PHQ-9 greater than or equal to 10) at the Screening visit;
- •14.History of psychotic symptoms requiri
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