[Translation] A multicenter, randomized, double-blind, placebo-controlled phase IIa clinical trial to evaluate the efficacy and safety of oral topical GB001 recombinant peptide spray in the treatment of mild recurrent aphthous ulcers
主要目的:
在成人轻型复发性阿弗他溃疡患者中,评价GB001重组多肽喷雾剂的有效性。
次要目的:
1)在成人轻型复发性阿弗他溃疡患者中,评价GB001重组多肽喷雾剂的药代动力学(Pharmacokinetics,PK)特征;
2)在成人轻型复发性阿弗他溃疡患者中,评价GB001重组多肽喷雾剂的免疫原性及安全性。
[Translation] Primary objective:
To evaluate the effectiveness of GB001 recombinant peptide spray in adult patients with mild recurrent aphthous ulcer.
Secondary objectives:
1) To evaluate the pharmacokinetic (PK) characteristics of GB001 recombinant peptide spray in adult patients with mild recurrent aphthous ulcer;
2) To evaluate the immunogenicity and safety of GB001 recombinant peptide spray in adult patients with mild recurrent aphthous ulcer.