[Translation] A single-center, randomized, double-blind, dose-escalation, placebo-controlled phase I clinical study evaluating the safety, tolerability, and pharmacokinetic characteristics of repeated oral topical administration of the antimicrobial peptide PL-3301 oral gel in healthy adult study participants.
主要目的:
评估抗菌肽PL-3301口腔凝胶在健康成年研究参与者中多次口腔局部给药的安全性和耐受性。
次要目的:
评估抗菌肽PL-3301口腔凝胶在健康成年研究参与者中多次口腔局部给药的药代动力学(PK)特征。
探索性目的:
1) 评估抗菌肽PL-3301口腔凝胶对健康成年研究参与者多次口腔局部给药后口腔黏膜以及微生物组学的影响;
2)评估抗菌肽PL-3301口腔凝胶在健康成年研究参与者中多次口腔局部给药后的免疫原性。
[Translation] Primary Objective: To evaluate the safety and tolerability of repeated oral topical administration of the antimicrobial peptide PL-3301 oral gel in healthy adult study participants.
Secondary Objective: To evaluate the pharmacokinetic (PK) characteristics of repeated oral topical administration of the antimicrobial peptide PL-3301 oral gel in healthy adult study participants.
Exploratory Objectives:
1) To evaluate the effects of repeated oral topical administration of the antimicrobial peptide PL-3301 oral gel on the oral mucosa and microbiome in healthy adult study participants;
2) To evaluate the immunogenicity of repeated oral topical administration of the antimicrobial peptide PL-3301 oral gel in healthy adult study participants.