[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.

Start Date18 Jul 2023

Sponsor / Collaborator

Zhejiang Echon Biopharm Limited

NCT06429566

/ Active, not recruitingPhase 2

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase IIa Clinical Trial to Evaluate the Efficacy and Safety of Oral Local Use of GB001 Recombinant Peptide Spray for the Treatment of Mild Recurrent Aphthous Ulcer

This trial is conducted in China. The purpose is to evaluate the efficacy, Pharmacokinetics (PK) profile, immunogenicity and safety of GB001 recombinant peptide spray in adults with mild recurrent aphthous ulcer.

Start Date18 Jul 2023

Sponsor / Collaborator

Zhejiang Echon Biopharm Limited

NCT05125211

/ Active, not recruitingPhase 1

A PhaseⅠRandomised, Double-blind, Placebo-controlled, Study to Evaluate the Safety, Tolerability, and Pharmacokinetics Characteristics of the Oral Topical Use of GB001 Recombinant Peptide Spray in Chinese Healthy Adult Subjects

This trial is conducted in China. The aim of this clinical trial is to assess the safety , tolerability and pharmacokinetics profiles of GB001 by single ascending dose and multiple ascending doses in healthy subjects after topical buccal delivery.

Start Date08 Aug 2022

Sponsor / Collaborator

Zhejiang Echon Biopharm Limited

100 Clinical Results associated with GB001 recombinant peptide (Zhejiang Yingkang Biopharmaceutical)

100 Translational Medicine associated with GB001 recombinant peptide (Zhejiang Yingkang Biopharmaceutical)

100 Patents (Medical) associated with GB001 recombinant peptide (Zhejiang Yingkang Biopharmaceutical)

100 Deals associated with GB001 recombinant peptide (Zhejiang Yingkang Biopharmaceutical)

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Recurrent aphthous ulcer	Phase 2	China	Zhejiang Echon Biopharm Limited	18 Jul 2023
Hand, Foot and Mouth Disease	Phase 1	China	Zhejiang Echon Biopharm Limited	08 Aug 2022
Herpangina	Phase 1	China	Zhejiang Echon Biopharm Limited	08 Aug 2022

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