[Translation] A single-center, randomized, double-blind, single-dose, dose-escalation, placebo-controlled phase Ia clinical study evaluating the safety, tolerability, and pharmacokinetic characteristics of the antimicrobial peptide iCAMP016 vaginal gel in healthy adult female volunteers.
主要目的:
评估抗菌肽iCAMP016阴道凝胶在健康成年女性志愿者中单次给药的安全性和耐受性。
次要目的:
评估抗菌肽iCAMP016阴道凝胶在健康成年女性志愿者中单次给药的药代动力学(PK)特征。
评估抗菌肽iCAMP016阴道凝胶在健康成年女性志愿者单次给药后阴道微生态变化。
探索性目的:
探索抗菌肽iCAMP016阴道凝胶在健康成年女性志愿者中单次给药前后的抗药抗体(ADA)阳性率情况。
[Translation] Primary Objective: To evaluate the safety and tolerability of a single-dose administration of the antimicrobial peptide iCAMP016 vaginal gel in healthy adult female volunteers.
Secondary Objective: To evaluate the pharmacokinetic (PK) characteristics of a single-dose administration of the antimicrobial peptide iCAMP016 vaginal gel in healthy adult female volunteers.
To evaluate changes in the vaginal microbiota following a single-dose administration of the antimicrobial peptide iCAMP016 vaginal gel in healthy adult female volunteers.
Exploratory Objective: To investigate the positivity rate of antimicrobial antibody (ADA) before and after a single-dose administration of the antimicrobial peptide iCAMP016 vaginal gel in healthy adult female volunteers.