NCT07603713尚未招募2 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Ⅱ Study to Evaluate the Efficacy and Safety of LP-005 Injection in Patients With Moderate-to-Severe Periodontitis
Longbio Pharma (Suzhou) Co., Ltd.1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年5月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study designed to evaluate the clinical efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of multiple local injections of different doses of LP-005 injection in patients with moderate-to-severe periodontitis, and to investigate changes in biomarker levels.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •Aged 18 to 70 years (inclusive), with no restriction on sex.
- •Clinically diagnosed with moderate to severe (Stage II or III) periodontitis according to the 2018 International Classification of Periodontal and Peri-Implant Diseases. participants must have at least 2 non-adjacent natural teeth (excluding third molars) in the dentition with a Probing Depth (PD) of 5 to 8 mm (inclusive), and at least 1 site per tooth with a BI score >
- •Participants and their partners must agree to practice effective non-pharmacological contraception from the time of signing the Informed Consent Form (ICF) until 3 months after the study completion. For female participants of childbearing potential, a negative pregnancy test result is required within 7 days prior to the first dose.
- •Voluntary participation in the trial and signed approval of the ICF.
排除标准
- •At the time of screening, the target tooth and/or adjacent teeth (as determined by the investigator to affect the target tooth) exhibit periapical periodontitis, pericoronitis, or combined pulp-periodontal lesions; or the participant has orthodontic appliances (including fixed lingual retainers, etc.);
- •At screening, the target tooth and/or adjacent teeth (as determined by the investigator to affect the target tooth) are found by the investigator to have severe caries or caries requiring immediate treatment;
- •At screening, the participant has a periodontal or dental abscess, or a tumor of the oral soft or hard tissues;
- •Participants who have previously undergone periodontal surgery on the target teeth and/or adjacent teeth (as determined by the investigator to affect the target teeth), or who have undergone subgingival scaling and root planning (SRP) within 6 months prior to screening;
- •Participants with a history of Neisseria meningitidis infection;
- •Participants with a history of splenectomy or congenital asplenia;
- •Participants with impaired immune function (e.g., HIV infection, neutropenia, complement deficiency, etc.);
- •Participants with autoimmune diseases that the investigator determines may interfere with the evaluation of the study disease, such as Sjögren's syndrome, systemic lupus erythematosus, psoriasis, rheumatoid arthritis, etc.;
- •Participants with poorly controlled blood pressure at screening, such as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg;
- •Participants with glycated hemoglobin (HbA1c) >7.5% or severe diabetic complications at screening;
- •Participants with severe or poorly controlled systemic diseases at screening, as determined by the investigator, such as respiratory, gastrointestinal, cardiovascular, hematological, urological, neurological, or psychiatric disorders;
- •Participants who have continuously taken medications deemed by the investigator to interfere with the study within 1 month prior to screening, such as nifedipine, phenytoin, or anticoagulants (e.g., warfarin);
- •Participants who have received systemic antibiotic therapy within 3 months prior to screening;
- •Participants who have taken nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids on a long-term basis (≥3 times per week) prior to screening;
- •Participants with any of the following laboratory test results at the time of screening:
- •ALT or AST > 2.5 times the upper limit of normal (ULN) or serum total bilirubin > 1.5 times ULN;
- •Serum creatinine > 1.5 times the upper ULN;
- •International Normalized Ratio (INR) ≥ 1.5 times ULN, or activated partial thromboplastin time (APTT) ≥ 1.5 times ULN (excluding participants currently receiving anticoagulant therapy);
- •Platelet count (PLT) < 100 × 10⁹/L;
- •Participants who test positive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or Treponema pallidum antibody (TP-Ab) at screening;
- •Participants with a history of malignant tumors within 5 years prior to screening;
- •Participants with a history of heavy smoking (≥10 cigarettes per day) within 12 months prior to screening;
- •Participants with known allergies to any drugs or materials used during surgery;
- •Pregnant or breastfeeding women;
- •Participants who have participated in other clinical trials within 30 days prior to screening or who plan to participate in other clinical trials during the study period;
- •Participants assessed by the investigator as having other conditions rendering them unsuitable for participation in the clinical study.
研究者
研究点 (1)
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