A Phase 1, Open-label, Non-Randomized Study to Evaluate the Safety and Tolerability of [Tc-99m]-RPI T-087 Injection as an Imaging Marker for COX-2 in Subjects With Osteoarthritis of the Knee Compared to Healthy Volunteers
试验速览
- 阶段
- 1 期
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Incidence of treatment emergent adverse events
研究概览
简要总结
The main purpose of this study is to test the safety and tolerability of T-087. The study will enroll 6 healthy volunteers (HVs) and 6-18 subjects with KOA. All eligible subjects will receive an intravenous injection of the radioactive investigational product (ip) (T-087), followed by SPECT/CT imaging of the knees and blood tests and clinical assessments for safety monitoring. Healthy volunteers will also have their whole body imaged and have extra blood drawn to determine where T-087 goes in the body. These additional procedures will be done on the same day as the ip administration, and repeated the following day. All subjects will have a final follow-up phone call within 2- 3 business days following the ip administration.
详细描述
This is a Phase 1, non-randomized, open label, single centre clinical trial. 6 healthy volunteers (3 male and 3 female,4 study visits) and 6-18 subjects with Osteoarthritis of the knee (3 study visits) will be enrolled. At visit 2, all subjects will have knee pain assessed, using a visual analogue scale, prior to receiving a single, 555 MBq (15 mCi)+/-10% dose of [Tc-99m)-RPI-T-087 injection. Knees will be imaged with a SPECT/CT camera at specified time-points post injection. Safety monitoring will include vital signs, ECG, clinical laboratory tests (serum biochemistry, haematology, urinalysis) and adverse event monitoring.
Additionally, HVs will have whole body planar imaging and blood sampling conducted at Visit 2 and 3 to evaluate bio-distribution, estimate dosimetry and measure clearance of total activity over time in blood samples. A final follow-up visit will be conducted by phone interview.
Once 6 HVs and 6 KOA participants have completed the study, a blinded assessment of the image data will be conducted to determine whether any more KOA subjects should be imaged.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Chronic pain conditions other than OA of the knee (KOA) as their predominant pain condition
- •Cannot or will not agree to stop: all topical, oral and parenteral non-steroidal anti-inflammatory drugs (NSAIDs) for at least 48 hours before administration of the IP; stop turmeric and curcumin (supplements and dietary sources) for at least 48 hours before administration of the IP; avoid all exercise from at least 24 hours before administration of the IP up to the end of the last applicable imaging session.
- •Systemic (including inhaled) and oral corticosteroid use currently or within 6 weeks prior to Visit
- •Surgical interventions of either knee or any other major surgery within the previous 6 months.
- •Receipt of intra-articular corticosteroid injections within the previous 6 weeks prior to Visit 1 in the target knee or within the previous 2 weeks prior to Visit 1 in any other joint.
- •Use of any other investigational medication or devices within 30 days prior to Visit
- •Orthopedic or prosthetic appliance in either knee which may confound scan interpretation.
- •Screening ECG or laboratory assessments showing clinically significant abnormalities
- •Refusal or inability to tolerate the scanning procedures
- •Allergies to or cannot tolerate NSAIDs, the investigational product or sulfa drugs
- •History of bleeding disorders or history of documented gastrointestinal ulcer disease.
- •Received significant ionizing radiation exposure, in the last 12 months or undergoing occupational monitoring for radiation exposure.
- •Allergies or sensitivity to any component of the investigational product. Subjects taking disulfiram (Antabuse) should be excluded from this study.
- •History of alcohol or substance abuse
- •Any medical condition or disease that in the opinion of the investigator makes the subject unsuitable to participate in this study.
研究组 & 干预措施
Healthy Volunteers
Healthy volunteers will be administered [Tc-99m]-RPI-T-087 Injection, single IV dose of 555 MBq and will be monitored for safety, knee image evaluation, and radioactivity biodistribution and dosimetry.
干预措施: [Tc-99m]-RPI-T-087 Injection (Drug)
Osteo Arthritis of the knee
Subjects with knee osteoarthritis will be administered [Tc-99m]-RPI-T-087 Injection, single IV dose of 555 MBq and will be monitored for safety and knee image evaluation.
干预措施: [Tc-99m]-RPI-T-087 Injection (Drug)
结局指标
主要结局
Incidence of treatment emergent adverse events
时间窗: Up to 3 days post investigative product administration
The incidence of adverse events, including injection site reactions, clinically significant changes in clinical laboratory parameters (blood and urine), ECG's and vital signs, will be summarized over time to assess safety and tolerability.
次要结局
- Uptake over time(Up to 4.5 hours post administration of the investigational product)
- Image quality(Up to 4.5 hours post administration of the investigational product)
- Dosimetry(Up to 1 day post administration of the investigational product.)