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ACTIVE NOT RECRUITING
NCT06429566
PHASE2

Safety and Efficacy Study of GB001 Recombinant Peptide Spray in Subjects With Mild Recurrent Aphthous Ulcers

Sponsor: Zhejiang Echon Biopharm Limited

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2023-07-18

Completion Date

2026-07-10

Last Updated

2025-04-09

Healthy Volunteers

No

Conditions

Interventions

DRUG

GB001 recombinant peptide spray low dose group、high dose group

Administrated oral spray. Each subject will take oral GB001 recombinant peptide spray 4 times a day, 4 sprays each time, no more than 29 times,The dosage of the group is 0.108mg/spray for low dose group and 0.216mg/spray for high dose group.

DRUG

GB001 recombinant peptide spray placebo

Administrated oral spray.Each subject will take oral GB001 recombinant peptide spray placebo 4 times a day, 4 sprays each time, no more than 29 times

Locations (1)

The First Hospital of Hunan University of Chinese Medicine

Changsha, Hunan, China