NCT03477487已完成1 期
Preliminary Evaluation of Safety, Tolerability, and Efficacy of XT-150 for the Treatment of Osteoarthritic Pain
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
研究概览
简要总结
Evaluation of Safety, Tolerability, and Efficacy of XT-150, a plasmid DNA with a variant of human IL-10 transgene. XT-150 will be a single injection into the knee synovial capsule for the Treatment of Osteoarthritic Pain.
详细描述
Phase 1 dose escalation study to evaluate the safety, tolerability, and efficacy of a plasmid DNA encoding a variant of human IL-10. This 6-month study will follow subjects with severe osteoarthritis of the knee. Safety labs, physical exams, and blood levels of the IL-10 variant will be assessed for tolerability and any adverse events associated with the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, between 18 and 90 years of age, inclusive
- •Sufficiently severe OA of the knee to meet accepted criteria for knee arthroplasty
- •Free of intra-articular infection, or infection at the injection site.
- •Symptomatic disease because of osteoarthritis, defined as one or more of the following Visual Analog Scale of Pain Intensity (VASPI) scores:
- •a worst pain of at least 70 at any time during the preceding week (based on scale of 0 to 100, with 100 representing "pain as bad as you can imagine").
- •a worst stiffness of at least 70 at any time during the preceding week (based on a scale of 0 to 100, with 100 representing "stiffness as bad as you can imagine").
- •Stable analgesic regimen during the 4 weeks prior to enrollment.
- •Inadequate pain relief (minimum ≥5 mean on the Brief Pain Inventory-Severity Scale) lasting ≥3 months.
- •In the judgment of the Investigator, acceptable general medical condition
- •Life expectancy >6 months
- •Female subjects of child-bearing potential, and those <1 year post-menopausal, must be practicing effective methods of birth control such as hormonal methods (e.g., combined oral, implantable, injectable, or transdermal contraceptives), double barrier methods (e.g., condoms, sponge, diaphragm) or total abstinence from heterosexual intercourse for a minimum of 1 month before study drug administration and agree to continue prevention methods for 3 months after participation in the study is completed.
- •Male subjects who are heterosexually active and not surgically sterile must agree to use effective contraception, including abstinence, for the duration of the study and for 3 months after the study is completed.
- •Have suitable knee joint anatomy for intra-articular injection
- •Willing and able to return for the follow-up (FU) visits
- •Able to reliably provide pain assessment
- •Able to read and understand study instructions, and willing and able to comply with all study procedures
排除标准
- •Hypersensitivity, allergy, or significant reaction to any ingredient of the study drug, including double-stranded DNA, mannose, and sucrose
- •Subject plans knee arthroplasty within 4 months, irrespective of the outcome of the trial or other conservative therapies
- •High peri-procedural risks which in the judgment of the investigator preclude a safe knee injection procedure (e.g., poorly controlled diabetes, cardiac inadequacy such as NYHA class > II, G4 glomerular filtration rate [eGFR < 30 mL/min by Cockcroft-Gault])
- •Current treatment with immunosuppressives (steroid therapy equivalent to >10mg/day prednisone); or other strong immunosuppressant
- •History of systemic immunosuppressive therapy; steroids (equivalent to >10mg/day prednisone) in the last 3 months
- •Currently receiving systemic chemotherapy or radiation therapy for malignancy
- •Clinically significant hepatic disease as indicated by clinical laboratory results ≥3 times the upper limit of normal for any liver function test (e.g., aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase)
- •Severe anemia (Grade 3; hemoglobin <8.0 g/dL, <4.9 mmol/L, <80 g/L; transfusion indicated), uncontrolled coagulopathy (Grade 1, prolonged activated partial prothrombin time (aPTT) > upper limit of normal (ULN) to 1.5xULN), or bleeding diathesis, Grade 1 white cell counts (lymphocytes <LLN - 800/mm3; <LLN - 0.8 x 10e9 /L, neutrophils <LLN - 1500/mm3; <LLN - 1.5 x 10e9 /L)
- •Positive serology for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus within 4 weeks of commencing the study
- •Significant neuropsychiatric conditions; dementia, major depression, or altered mental state that in the opinion of the Investigator will interfere with study participation
- •Current treatment with systemic antibiotics or antivirals (EXCEPTION: topical treatments)
- •Current treatment with anticoagulants, other than low-dose aspirin, prescribed for new onset of symptoms in 3 months before screening visit.
- •Known or suspected history of active alcohol or intravenous/oral drug abuse within 1 year before the screening visit
- •Women who are pregnant or nursing
- •Use of any investigational drug or device within 1 month before enrollment or current participation in a trial that included intervention with a drug or device; or currently participating in an investigational drug or device study.
- •Any condition that, in the opinion of the Principal Investigator, could compromise the safety of the subject, the subject's ability to communicate with the study staff, or the quality of the data
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
时间窗: 6 months
Clinical, laboratory measures of safety by CTCAE v4.0
次要结局
- WOMAC(6 Months)
- Visual Analog Scale of Pain Intensity(6 months)
- Knee Injury and Osteoarthritis Outcomes Scale(6 months)
- Brief Pain Inventory(6 months)
研究者
研究点 (2)
Loading locations...
相似试验
招募中
1 期
A Phase I Study on Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of SXRN Plasmid DNA Technique in Patients With Advanced Solid TumorsAdvanced CancerCachexiaNCT06736275Jiangsu Nutai Biologics Co., Ltd28
已完成
1 期
Safety and Effectiveness of PENNVAX-B Vaccine Alone, With Il-12, or IL-15 in Healthy AdultsHIV InfectionsNCT00528489National Institute of Allergy and Infectious Diseases (NIAID)120
进行中（未招募）
1 期
Phase I/II, FIH, Dose Escalation Trial of TL-895 and Expansion of TL-895 Monotherapy and Combination Therapy With Navtemadlin in Tx-Naïve and R/R CLL/SLL SubjectsRelapsed/Refractory B Cell MalignanciesMantle Cell Lymphoma and Diffuse Large B Cell LymphomaSmall Lymphocytic LymphomaTreatment-Naive B Cell MalignanciesChronic Lymphocytic LeukemiaNCT02825836Telios Pharma, Inc.130
已完成
1 期
Safety of and Immune Response to a DNA HIV Vaccine Followed By Boosting With One of Two Serotypes of Adenoviral Vector HIV Vaccine in Healthy AdultsHIV InfectionsNCT00472719National Institute of Allergy and Infectious Diseases (NIAID)17
已完成
2 期
ILT-101 in Patients With Active Moderate to Severe Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusNCT02955615Iltoo Pharma100