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

April 8, 2025 updated by: Zhejiang Echon Biopharm Limited

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410000
        • The First Hospital of Hunan University of Chinese Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. It meets the diagnostic criteria for mild recurrent Aphthous ulcer in the fifth edition of Oral Mucosa published by People's Medical Publishing House in 2020.
  2. 18≤ age ≤65 years old, gender is not limited.
  3. Patients with untreated target ulcer onset ≤48 hours at the time of screening.
  4. VAS score of target ulcer irritation pain ≥3 points, 2mm≤ length diameter of target ulcer ≤10mm.
  5. Subjects and their sexual partners agree to use effective contraception during the study period and for at least 30 days after the study ends.
  6. Sign a written informed consent, and be able to comply with the visit and related procedures stipulated in the program.

Exclusion criteria:

  1. The diagnosis was severe aphthous ulcer, herpetic aphthous ulcer, acute herpetic gingivitis stomatitis, traumatic ulcer, cancerous ulcer, tuberculous ulcer, syphilitic ulcer, necrotic salivate metaplasia, Behcet disease and other diseases or drug induced ulcers.
  2. Patients with suppurative tonsillitis or other painful lesions in the mouth, such as pericoronitis, pulpitis, periapical inflammation, etc., affecting the pain score of target ulcer.
  3. Target ulcer is affected by residual root, residual crown, denture, prosthesis, orthodontic device and other stimulating factors in the corresponding parts of the target ulcer.
  4. The ulcer is located in the lingual frenulum, the back wall of the pharynx and other parts, and its size is not easy to measure.
  5. Those who plan to perform other oral treatments during the trial that affect the determination of drug effectiveness and safety.
  6. Smokers > 20 cigarettes/day or betel nut lovers in the past 3 months.
  7. People who have used painkillers or drugs that may affect the efficacy of pain observation within 24 hours before the first administration, such as sedatives, anti-allergy drugs, non-steroidal anti-inflammatory drugs, etc.
  8. Patients who have used antibiotics or antiviral drugs locally or systematically within 1 week before screening.
  9. Patients who had used immunosuppressive agents locally within 1 week before screening or systemic immunosuppressive agents within 2 weeks before screening.
  10. Patients with oral local or systemic use of glucocorticosteroids within 4 weeks prior to screening.
  11. Patients who have taken anticholinergic drugs to reduce salivary secretion within 2 weeks prior to screening.
  12. Complicated with severe liver and kidney diseases, or abnormal liver and kidney function tests (ALT and AST≥ 1.5 times the upper limit of normal, SCr > the upper limit of normal).
  13. Patients with severe anemia (Hb < 60g/L).
  14. Complicated with severe heart and lung disease, uncontrolled diabetes (fasting blood glucose > 7.0mmol/L or random blood glucose ≥11.1mmol/L), advanced tumors, diseases of the blood and hematopoietic system, or other serious or progressive diseases of the system.
  15. Known or suspected allergic history or serious adverse reactions to the experimental drug and its excipients.
  16. Pregnant or lactating women and those with recent pregnancy plans.
  17. Participants who had participated in other interventional clinical trials within 3 months prior to screening.
  18. Other conditions deemed inappropriate by the investigator for participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: GB001 recombinant peptide spray low dose group
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.
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.
Experimental: GB001 recombinant peptide spray high dose group
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 0.216mg/spray.
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.
Experimental: Placebo group
Each subject will take oral GB001 recombinant peptide spray 4 times a day, 4 sprays each time, for 8 days.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Target ulcer healing rate for patients in day 6
Time Frame: Day 6
Ulcer healing was defined as disappearance of pain and zeroing of ulcer size. At the screening visit the ulcer area and pain severity of patient to clinical examination will be rated at baseline. The patients will be self-assessment pain severity in vas score sheet every day . And the patients will be re-examined in day 6 to assess the ulcer area by periodontal probe.
Day 6
Subjects self-rated the time it took for irritation pain to disappear
Time Frame: Day 8
Day 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time for target ulcer to heal
Time Frame: Day 8
Ulcer healing was defined as disappearance of pain and zeroing of ulcer size.The patients will be self-assessment pain severity in vas score sheet every day . And the patients will be re-examined to assess the ulcer area by periodontal probe.
Day 8
Targeted ulcer healing rate for patients in day 4 and day 8
Time Frame: Day 4,Day 8
Ulcer healing was defined as disappearance of pain and zeroing of ulcer size. At the screening visit the ulcer area and pain severity of patient to clinical examination will be rated at baseline. The patients will be self-assessment pain severity in vas score sheet every day . And the patients will be re-examined in day 4 and day 8 to assess the ulcer area by periodontal probe.
Day 4,Day 8
Changes in target ulcer area relative to baseline
Time Frame: Day 4,Day 6,Day 8
At the screening visit the ulcer area of patient to clinical examination will be rated at baseline. And the patients will be re-examined in day 4、day 6 and day 8 to assess the ulcer area by periodontal probe.
Day 4,Day 6,Day 8
Self evaluation of pain disappearance rate and relief rate
Time Frame: Day 4,Day 6,Day 8
Day 4,Day 6,Day 8
Pharmacokinetics Characteristics， t½ of GB001 Recombinant Peptide
Time Frame: Day 1,Day 4
Apparent terminal phase half-life
Day 1,Day 4
Pharmacokinetics Characteristics，AUC of GB001 Recombinant Peptide
Time Frame: Day 1,Day 4
Area under the plasma concentration versus time curve
Day 1,Day 4
Pharmacokinetics Characteristics， Cmax of GB001 Recombinant Peptide
Time Frame: Day 1,Day 4
Maximum plasma concentration
Day 1,Day 4
Pharmacokinetics Characteristics， Tmax of GB001 Recombinant Peptide
Time Frame: Day 1,Day 4
Time of maximum plasma concentration
Day 1,Day 4
Immunogenicity(drug resistant antibody (ADA))
Time Frame: Day 1,Day 14,Day 28
Day 1,Day 14,Day 28
Incidence of Adverse Events
Time Frame: First dose to last visit,an average of 1 month.
First dose to last visit,an average of 1 month.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhejiang Echon Biopharm Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 18, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 6, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 10, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 28, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • YK2019L01P-IIa

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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