[Translation] A randomized, double-blind, placebo-controlled phase I clinical trial evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy of PD-DP-008 in healthy adult subjects and patients with mild to moderate acne vulgaris in China.
主要目的:
评价PD-DP-008在健康受试者单、多次局部外用给药及在轻中度寻常痤疮患者中多次局部外用给药的安全性和耐受性。
次要目的:
评价PD-DP-008在健康受试者单、多次局部外用给药及在轻中度寻常痤疮患者中多次局部外用给药的药代动力学(Pharmacokinetics,PK)特征;
评价PD-DP-008在健康受试者单、多次局部外用给药及在轻中度寻常痤疮患者中多次局部外用给药的免疫原性;
评价PD-DP-008在轻中度寻常痤疮患者中多次局部外用给药的初步有效性(仅患者面部,Ib期)。
[Translation] Primary Objective: To evaluate the safety and tolerability of PD-DP-008 in healthy subjects with single and multiple topical administration, and in patients with mild to moderate acne vulgaris with multiple topical administration.
Secondary Objectives: To evaluate the pharmacokinetic (PK) characteristics of PD-DP-008 in healthy subjects with single and multiple topical administration, and in patients with mild to moderate acne vulgaris with multiple topical administration; to evaluate the immunogenicity of PD-DP-008 in healthy subjects with single and multiple topical administration, and in patients with mild to moderate acne vulgaris with multiple topical administration; to evaluate the preliminary efficacy of PD-DP-008 in patients with mild to moderate acne vulgaris with multiple topical administration (face only, stage Ib).