[Translation] A Phase I clinical study evaluating the safety, tolerability, and pharmacokinetic profile of a single topical oral 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单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单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单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单次口腔局部给药后药物经肾脏途径排泄率;
3)评估抗菌肽PL-3301口腔凝胶在健康成年研究参与者中单次口腔局部给药后的免疫原性。
[Translation] Primary Objective:
To evaluate the safety and tolerability of a single topical oral administration of the antimicrobial peptide PL-3301 oral gel in healthy adult study participants.
Secondary Objective:
To evaluate the pharmacokinetic (PK) profile of a single topical oral administration of the antimicrobial peptide PL-3301 oral gel in healthy adult study participants.
Exploratory Objectives:
1) To evaluate the effects of a single topical oral administration of the antimicrobial peptide PL-3301 oral gel on the oral mucosa and microbiome in healthy adult study participants;
2) To evaluate the renal excretion rate of the antimicrobial peptide PL-3301 oral gel in healthy adult study participants;
3) To evaluate the immunogenicity of the antimicrobial peptide PL-3301 oral gel in healthy adult study participants after a single topical oral administration.