NCT05419856已完成1 期
A Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Doses of 4P004 Versus Placebo Injected in the Target Knee of Patients With Grade 2 to 4 Osteoarthritis on the Kellgren and Lawrence Severity Index
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 3
- 主要终点
- Safety and Tolerability of Single IA Administration of 4P-004 at Escalating Doses in Participants With Knee OA.
研究概览
简要总结
This phase I study is a multicenter, randomized, double-blind, placebo-controlled study to assess the safety and tolerability of single ascending dose of IA 4P-004 in participants,
- Between 18 and 80 years of age,
- with target knee OA stage KL 2-4 A total of 32 participants will be enrolled in 4 cohorts, in each cohort participants will receive either 4P-004 or placebo (6:2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who have the capacity to give informed consent and who are willing to comply with all study related procedures and assessments (consent via legally authorized representative will not be accepted),
- •Ambulatory participants, agreeing a 24-hour hospitalization,
- •Participants between 18 and 80 years of age,
- •Female participant of childbearing potential (WOCBP), must use contraceptive consistent with local regulations regarding the methods of contraception for those participating in clinical studies (see section 11.4) for at least 5 days following IMP injection, and must have a negative urine pregnancy test done within 24h before randomization,
- •Male participants (whose partners are of childbearing potential) must consent to use methods of contraception consistent with local regulations regarding the methods of contraception for those participating in clinical studies (see section 11.4), for at least 90 days following IMP injection,
- •Participants with knee osteoarthritis, KL 2-4 of their target knee (defined at screening as the knee with greater pain based on the participant's evaluation and the investigator's clinical judgment),
- •X-rays of the target knee within 6 months (if not, to be performed before randomization),
- •ECG within normal range,
- •WBC (white blood cell count) > 3500/µL,
- •Hemoglobin > 12 g/dL,
- •Platelets > 100,000/ µL,
- •Creatinine clearance (CrCl) > 60 mL/min,
- •Glycemia within normal range,
- •AST, ALT < 1.5 upper limit of normal (ULN),
- •Amylasemia < 1ULN,
- •Negative tests for COVID-19 (if required by the standard practice on site), HIV, HbsAg and hepatitis C Ab (Determination of HIV and hepatitis status can be based on participant-reported medical history, available medical records, and the most recently available laboratory results for the participant [tests performed within the previous 12 months]).
排除标准
- •Breastfeeding women,
- •Treatment with systemic glucocorticoids greater than 10 mg prednisone or the equivalent per day within 4 weeks prior to screening,
- •Any treatment with glucosamine or chondroitin sulfate in the previous 3 months,
- •Any glucagon-like peptide 1 analogue hormones,
- •Anticoagulant treatment (current or within the last 10 days),
- •Treatment of the target knee with any IA injection (steroids, hyaluronic acid derivatives, PRP ....) within 3 months,
- •Knee surgery (of the target knee) performed within the previous 12 months or planned within the next 6 months,
- •Any partial knee replacement of the target knee,
- •Any known active infections or increased predisposition for the development of infections
- •Clinical signs and symptoms of active joint crystal disease, or any inflammatory joint disease,
- •Diabetes type I or II,
- •Congestive Heart Failure stage III or IV of NYHA classification,
- •Inflammatory bowel disease,
- •Any other chronic condition that has not been well controlled for a minimum of 3 months,
- •History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer) within the last 5 years,
- •Any condition, including laboratory findings, that in the opinion of the investigator constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct or evaluation, (for example, any abnormal reaction to previous IA injection),
- •Hypersensitivity to the active substance liraglutide or to any of the excipients: Disodium phosphate dihydrate, Propylene glycol, Phenol,
- •Participation in an interventional clinical research trial within 12 weeks prior.
研究组 & 干预措施
4P-004 w mg
Experimental
4P-004 is administered once intraarticularly in the target knee joint Dose = w mg
干预措施: 4P-004 (Drug)
4P-004 x mg
Experimental
4P-004 is administered once intraarticularly in the target knee joint Dose = x mg
干预措施: 4P-004 (Drug)
4P-004 y mg
Experimental
4P-004 is administered once intraarticularly in the target knee joint Dose = y mg
干预措施: 4P-004 (Drug)
4P-004 z mg
Experimental
4P-004 is administered once intraarticularly in the target knee joint Dose = z mg
干预措施: 4P-004 (Drug)
Placebo
Placebo Comparator
Placebo is administered once intraarticularly in the target knee joint
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and Tolerability of Single IA Administration of 4P-004 at Escalating Doses in Participants With Knee OA.
时间窗: Day 1-Day 28
Number of participants with Adverse Events, serious AEs (SAEs), with abnormal Vital signs, abnormal ECG reading and abnormal Laboratory test results
次要结局
- To Characterize the Plasma Concentration of Liraglutide When Administered as Single IA Doses at Escalating Dose Levels in Participants With Knee OA(Day 1 to Day 2)
研究者
研究点 (3)
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