計劃書編號OEP-2PM102-201
NCT Number(ClinicalTrials.gov Identfier)NCT05807529
試驗已結束
2022-09-01 - 2024-12-31
Phase I/II
尚未開始1
召募中11
ICD-10M19.90
未明示部位骨關節炎
ICD-9715.38
局部骨關節病，其他特定部位
一項劑量遞增、雙盲、安慰劑對照及劑量探索之第一期與第二期臨床試驗，用以評估膝部骨關節炎患者使用 2ccPA 的安全性及療效
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試驗申請者
友華生技醫藥股份有限公司
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試驗委託 / 贊助單位名稱
友華生技醫藥股份有限公司
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臨床試驗規模
台灣多中心
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更新日期
2026/02/01
試驗主持人及試驗醫院
實際收案人數
0 召募中
實際收案人數
0 召募中
實際收案人數
0 召募中
實際收案人數
0 召募中
實際收案人數
0 尚未開始
實際收案人數
0 召募中
適應症
膝部骨關節炎
試驗目的
這是一項第 I與II 期試驗，目的在評估 2ccPA 單劑量 4,800 μg 及 7,200 μg 用在膝部骨關節炎 (osteoarthritis, OA) 患者的安全性 (第 1 期)，以及評估 2ccPA 多劑量的安全性及療效 (第 2 期)。
藥品名稱
注射液劑
主成份
2-carba-cyclic phosphatidic acid
劑型
27D
劑量
2.4 mg/mL
評估指標
第 1 期
主要評估指標
•2ccPA 安全性
-不良事件 (adverse event, AE) 及嚴重不良事件的發生率(serious adverse event, SAE)
-實驗室檢查結果變化
-生命徵象變化
-身體檢查發現
-判定 最大耐受劑量，當某一劑量觀察到 大於或等於 1/3 接受 2ccPA 的受試者發生DLT 時，該劑量的前的一個劑量等級定義為 最大耐受劑量。如果在降低劑量組別中 小於1/3 受試者發生DLT，最大耐受劑量 將設定為該降低的劑量；如果在該降低劑量組別中 大於或等於 1/3 受試者發生DLT，則前一個劑量組別的劑量等級將設定為 最大耐受劑量。
第 2 期
主要評估指標
•WOMAC 在第 85 天自基準點的絕對變化
主要評估指標
•2ccPA 安全性
-不良事件 (adverse event, AE) 及嚴重不良事件的發生率(serious adverse event, SAE)
-實驗室檢查結果變化
-生命徵象變化
-身體檢查發現
-判定 最大耐受劑量，當某一劑量觀察到 大於或等於 1/3 接受 2ccPA 的受試者發生DLT 時，該劑量的前的一個劑量等級定義為 最大耐受劑量。如果在降低劑量組別中 小於1/3 受試者發生DLT，最大耐受劑量 將設定為該降低的劑量；如果在該降低劑量組別中 大於或等於 1/3 受試者發生DLT，則前一個劑量組別的劑量等級將設定為 最大耐受劑量。
第 2 期
主要評估指標
•WOMAC 在第 85 天自基準點的絕對變化
主要納入條件
1.有能力給予同意並已簽署本受試者同意書。
2.年齡介於40至80歲（含）的男性或女性。
3.篩選前至少6個月，至少有一邊膝蓋有症狀性膝部骨關節炎的診斷記錄。
4.依據Kellgren Lawrence 分級量表，試驗膝蓋的 OA 嚴重度為第 2 至 3 級。
5.試驗膝蓋依據 WOMAC疼痛子量表分數 ＞ 6分 且 ＜ 16分，總分 20 分。
6.隨機分配前 30 天內，試驗膝蓋多數時間會感覺疼痛(即超過一半的天數)。
7.若是有生育能力的女性受試者，從篩選回診直到試驗藥物治療後至少 1 個月，必須同意使用醫學上認可的避孕方法，且在試驗治療前72 小時之內必須驗孕結果陰性。若是男性受試者從，篩選回診直到試驗藥物治療後至少 1 個月必須同意使用醫學上認可的避孕方法 (即，絕育手術、屏障阻隔法、禁慾)。
2.年齡介於40至80歲（含）的男性或女性。
3.篩選前至少6個月，至少有一邊膝蓋有症狀性膝部骨關節炎的診斷記錄。
4.依據Kellgren Lawrence 分級量表，試驗膝蓋的 OA 嚴重度為第 2 至 3 級。
5.試驗膝蓋依據 WOMAC疼痛子量表分數 ＞ 6分 且 ＜ 16分，總分 20 分。
6.隨機分配前 30 天內，試驗膝蓋多數時間會感覺疼痛(即超過一半的天數)。
7.若是有生育能力的女性受試者，從篩選回診直到試驗藥物治療後至少 1 個月，必須同意使用醫學上認可的避孕方法，且在試驗治療前72 小時之內必須驗孕結果陰性。若是男性受試者從，篩選回診直到試驗藥物治療後至少 1 個月必須同意使用醫學上認可的避孕方法 (即，絕育手術、屏障阻隔法、禁慾)。
主要排除條件
Exclusion Criteria:
Patients with known or suspected hypersensitivity to 2ccPA or any of its excipients.
Use of intra-articular corticosteroids, hyaluronic acid, or other IA injection in the study knee within 3 months prior to study entry (randomization).
Use of chondroitin and/or glucosamine within 4 weeks prior to study entry (randomization).
Administered or requiring systemic or topical treatment of the study knee joint including immunosuppressive agents, anti-inflammatory drugs, steroids, or opioids for knee OA within 1 week prior to randomization. Acetaminophen (oral daily dose ≤ 3000 mg or topical use at any dose) can be taken up to 24 hours prior to randomization. For long-acting steroids (i.e., dexamethasone, betamethasone), subjects who received systemic treatment within 2 weeks before randomization will be excluded.
History of post-traumatic knee arthritis, or evidence of intra-articular bleeding of the study knee.
History of reiter's syndrome, gouty arthritis, systemic lupus erythematosus (SLE), sicca syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, lymphoma, arthritis associated with inflammatory bowel disease, sarcoidosis, amyloidosis or any other immune disease that based on investigators' discretion.
Periarticular inflammation from any cause, including referred pain, bursitis, tendonitis, soft tissue tenderness or acute pain from injury.
Subjects with clinical signs and symptoms of active knee infection or being treated for knee infection at screening.
Arthroscopic or open surgery on the study knee within 6 months prior to study entry (randomization).
Prior knee replacement on the study knee or planned knee replacement during the study period.
Subjects with meniscus tears that require repairment surgery or known anterior cruciate ligament rupture.
Subjects with known severe synovitis, synovium necrosis in the study knee joint.
Subjects with known malignancy.
Use of any chemotherapeutic or systemic immunosuppressant agents for inflammatory diseases within 6 months prior to study entry (randomization).
Current use of anticoagulants, including warfarin, heparin, low molecular weight heparin, dabigatran, or factor Xa inhibitors (rivaroxaban, apixaban, edoxaban, and betrixaban). Subject requiring routine use of low-dose aspirin for preventing thrombosis (≤ 100 mg/day) will not be excluded.
Abnormalities of laboratory parameters as described below will qualify for exclusion:
hemoglobin < 8 g/dL
total white blood cell count < lower limit of normal (LLN)
serum bilirubin/ alanine aminotransferase (ALT)/ aspartate aminotransferase AST > 2.5 times upper limit of normal (ULN)
serum creatinine > 2 times ULN
Pregnancy or lactation.
History of drug or alcohol dependence in the past 3 years.
Having known infection with HIV-1, active hepatitis B, or active hepatitis C. Patients who are inactive carriers of HBV or HCV can be enrolled if the subjects have stable baseline condition during the screening period.
Use of any investigational drug or participation in any drug study within 4 weeks prior to study entry (randomization).
Subjects unwilling or unable to comply with study procedures.
Any clinical condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk to participate in the study or confounds the ability to interpret data from the study as judged by the investigator.
Patients with known or suspected hypersensitivity to 2ccPA or any of its excipients.
Use of intra-articular corticosteroids, hyaluronic acid, or other IA injection in the study knee within 3 months prior to study entry (randomization).
Use of chondroitin and/or glucosamine within 4 weeks prior to study entry (randomization).
Administered or requiring systemic or topical treatment of the study knee joint including immunosuppressive agents, anti-inflammatory drugs, steroids, or opioids for knee OA within 1 week prior to randomization. Acetaminophen (oral daily dose ≤ 3000 mg or topical use at any dose) can be taken up to 24 hours prior to randomization. For long-acting steroids (i.e., dexamethasone, betamethasone), subjects who received systemic treatment within 2 weeks before randomization will be excluded.
History of post-traumatic knee arthritis, or evidence of intra-articular bleeding of the study knee.
History of reiter's syndrome, gouty arthritis, systemic lupus erythematosus (SLE), sicca syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, lymphoma, arthritis associated with inflammatory bowel disease, sarcoidosis, amyloidosis or any other immune disease that based on investigators' discretion.
Periarticular inflammation from any cause, including referred pain, bursitis, tendonitis, soft tissue tenderness or acute pain from injury.
Subjects with clinical signs and symptoms of active knee infection or being treated for knee infection at screening.
Arthroscopic or open surgery on the study knee within 6 months prior to study entry (randomization).
Prior knee replacement on the study knee or planned knee replacement during the study period.
Subjects with meniscus tears that require repairment surgery or known anterior cruciate ligament rupture.
Subjects with known severe synovitis, synovium necrosis in the study knee joint.
Subjects with known malignancy.
Use of any chemotherapeutic or systemic immunosuppressant agents for inflammatory diseases within 6 months prior to study entry (randomization).
Current use of anticoagulants, including warfarin, heparin, low molecular weight heparin, dabigatran, or factor Xa inhibitors (rivaroxaban, apixaban, edoxaban, and betrixaban). Subject requiring routine use of low-dose aspirin for preventing thrombosis (≤ 100 mg/day) will not be excluded.
Abnormalities of laboratory parameters as described below will qualify for exclusion:
hemoglobin < 8 g/dL
total white blood cell count < lower limit of normal (LLN)
serum bilirubin/ alanine aminotransferase (ALT)/ aspartate aminotransferase AST > 2.5 times upper limit of normal (ULN)
serum creatinine > 2 times ULN
Pregnancy or lactation.
History of drug or alcohol dependence in the past 3 years.
Having known infection with HIV-1, active hepatitis B, or active hepatitis C. Patients who are inactive carriers of HBV or HCV can be enrolled if the subjects have stable baseline condition during the screening period.
Use of any investigational drug or participation in any drug study within 4 weeks prior to study entry (randomization).
Subjects unwilling or unable to comply with study procedures.
Any clinical condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk to participate in the study or confounds the ability to interpret data from the study as judged by the investigator.
試驗計畫預計收納受試者人數
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台灣人數
136 人
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全球人數
0 人
