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NOT YET RECRUITING
NCT07603713
PHASE2

Efficacy and Safety of LP-005 Injection in Patients With Moderate-to-Severe Periodontitis

Sponsor: Longbio Pharma (Suzhou) Co., Ltd.

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-05-01

Completion Date

2027-03-23

Last Updated

2026-05-22

Healthy Volunteers

No

Conditions

Interventions

DRUG

LP-005 Injection

LP-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.

DRUG

Placebo Injection

Placebo is a sterile injectable solution matched to LP-005 for appearance, formulation, and administration, with 0 mg of active ingredient per 6 mL vial.

Locations (1)

Peking University School and Hospital of Stomatology

Beijing, Beijing Municipality, China