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.
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 > 2.
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.
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;
Parallel
LP-005 Injection
DrugLP-005 is a bifunctional antibody fusion protein consisting of an anti-human C5 monoclonal antibody and a human complement regulatory protein, formulated as a sterile injectable solution. Each vial contains 300 mg of LP-005 in 6 mL (50 mg/mL). The LP-005 is administered via interdental papilla injection.
Placebo Injection
DrugPlacebo is a sterile injectable solution matched to LP-005 for appearance, formulation, and administration, with 0 mg of active ingredient per 6 mL vial.
Change from Baseline in Gingival Index (GI)
GI is measured using the Löe-Silness scale (range: 0-3), where higher scores indicate more severe gingival inflammation (worse outcome). Changes from baseline in gingival index (GI) scores are measured at Day 43, Day 85, Day 127, and Day 169 after the first administration of LP-005 injection.
Change from Baseline in Bleeding Index (BI)
BI is measured using the Caton-Paton scale (range: 0-4), where higher scores indicate more severe gingival bleeding (worse outcome). Changes from baseline in BI scores are measured at Day 43, Day 85, Day 127, and Day 169 after the first administration of LP-005 injection.
Change from Baseline in Probing Pocket Depth (PD)
Changes from baseline in probing pocket depth (PD) are measured at Day 43, Day 85, Day 127, and Day 169 after the first administration of LP-005 injection.
Change from Baseline in Clinical Attachment Loss (AL)
Clinical AL is evaluated by standardized periodontal probing: after measuring probing depth, the probe tip is withdrawn along the root surface to identify the cemento-enamel junction (CEJ). The distance from the CEJ to the gingival margin (GM) is recorded. AL is calculated by subtracting this distance from the probing depth. A result of zero or an undetectable CEJ indicates no attachment loss. In cases of gingival recession where the gingival margin is apical to the CEJ, AL is determined by summing the two measurements. Six sites per tooth are examined, and AL values are recorded at all measured sites, with units expressed in millimeters (mm); larger values represent more severe periodontal attachment destruction. Changes from baseline in AL are measured at Day 43, Day 85, Day 127, and Day 169 after the first administration of LP-005 injection.
Change from Baseline in Gingival Crevicular Fluid (GCF) Biomarker Levels
GCF samples will be collected in participants' GCF after local administration of LP-005 to assess changes from baseline in a predefined panel of inflammatory and tissue-degrading biomarkers, including C3b, C5a, IL-1β, IL-6, TNF-α, MMP-8, and MMP-9. All biomarkers are quantified in standardized protein concentration units within GCF, and individual biomarker changes will be reported separately without aggregation.
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