A Randomized, Double-blinded, Placebo-controlled, Phase I/II Study to Evaluate the Safety and Preliminary Efficacy of Single Administration of AGA111 for Lumbar Interbody Fusion in Patients With Degenerative Disc Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Number of participants with adverse events (AEs)
研究概览
简要总结
The objectives of the study are to evaluate the safety and preliminary efficacy of a single administration of AGA111 for lumbar interbody fusion in patients with degenerative disc disease.
详细描述
A randomized, double-blind, placebo-controlled, phase 1/2 study to evaluate the safety and preliminary efficacy of single administration of AGA111 for lumbar interbody fusion in patients with degenerative disc disease. A total of 60 participants will be enrolled and randomized to placebo, AGA111 0.25 mg, or AGA111 0.5 mg at 1: 1: 1 ratio. All participants will undergo lumbar interbody fusion and receive study treatment during the surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and capable of giving signed informed consent.
- •Male or female, age between 40-80 years.
- •Male or female of childbearing potential must agree to use a highly effective contraception throughout the entire study period, and female subjects must have a negative pregnancy test prior to the randomization.
- •Has degenerative disc disease (DDD) of the lumbosacral(L3-S1) spine that results in back pain, with or without radiating leg pain.
- •Has radiographic evidence (e.g. CT, MRI, x-ray, etc.) of degenerative disc disease.
- •Planning to receive single-level lumbar interbody fusion.
- •Willing and capable of adhering to the protocol and visit schedule.
排除标准
- •Prior surgical procedure at the involved or adjacent spinal levels.
- •Presence or prior history of inflammatory disease of the spine.
- •Presence or prior history of neoplastic disease of the spine.
- •BMI <18.5 or BMI >
- •Documented titanium allergy or intolerance.
- •Presence or prior history of malignancy (except for fully resected basal cell carcinoma of the skin).
- •Presence or history of an uncontrolled, unstable, clinically significant medical condition that, in the opinion of the investigator, could jeopardize or compromise the subject's safety or ability to participate in this study.
- •Active local or systemic infection.
- •Female subject who is pregnant or lactating.
- •Serological evidence of positive human immunodeficiency virus (HIV) antibody.
- •HBsAg positive or HBeAg positive, along with positive HBV DNA test.
- •Serological evidence of HCV antibody, along with HCV RNA > lower limit of detection.
- •Known drug or alcohol abuser.
研究组 & 干预措施
0.25 mg AGA111
0.25 mg AGA111 in autologous blood coagulum (ABC) is locally delivered at the intervertebral space.
干预措施: AGA111 (Drug)
0.5 mg AGA111
0.5 mg AGA111 in ABC is locally delivered to the participants at the intervertebral space.
干预措施: AGA111 (Drug)
Placebo
Placebo in ABC is locally delivered at the intervertebral space.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with adverse events (AEs)
时间窗: Up to 12 months
An adverse event (AE) is any untoward medical occurrence in clinical study participant, temporally associated with the use of the investigational product (IP), whether or not considered related to the IP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IP.
Number of participants who develop anti-drug antibody to AGA111
时间窗: Up to 90 days post operation
Blood samples taken prior to the operation and 5 days, 28 days and 90 days post operation were tested for anti-AGA111 antibodies using an immunoassay method.
次要结局
- Radiographic fusion success(Up to 12 months post operation)
- New Bone formation(Up to 12 months post operation)
- Oswestry Disability Index (ODI)(Up to 12 months post operation)
- Pain score through Visual Analogue Scale (VAS)(Up to 12 months post operation)
- Maximum Concentration (Cmax) of AGA111(90 minutes before administration, and 30 minutes, 1 hour, 6 hours, and 24 hours post administration.)
- Time to maximum concentration (Tmax) of AGA111(90 minutes before administration, and 30 minutes, 1 hour, 6 hours, and 24 hours post administration.)
- Area under the concentration time curve (AUC)(90 minutes before administration, and 30 minutes, 1 hour, 6 hours, and 24 hours post administration.)