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HealthyPhase 2NCT06429566

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

A Phase 2 study testing GB001 recombinant peptide spray low dose group、high dose group in people with Healthy, run by Zhejiang Echon Biopharm Limited at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Healthy
What is being tested?
GB001 recombinant peptide spray low dose group、high dose group
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteChina
Study dates
18 Jul 2023to 10 Jul 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 18≤ age ≤65 years old, gender is not limited.
  • Patients with untreated target ulcer onset ≤48 hours at the time of screening.
  • VAS score of target ulcer irritation pain ≥3 points, 2mm≤ length diameter of target ulcer ≤10mm.
  • Subjects and their sexual partners agree to use effective contraception during the study period and for at least 30 days after the study ends.
  • Sign a written informed consent, and be able to comply with the visit and related procedures stipulated in the program.

Who cannot join

  • 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.
  • 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.
  • 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.
  • 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.
  • Those who plan to perform other oral treatments during the trial that affect the determination of drug effectiveness and safety.
  • Smokers > 20 cigarettes/day or betel nut lovers in the past 3 months.
Show all 18Show fewer
  • 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.
  • Patients who have used antibiotics or antiviral drugs locally or systematically within 1 week before screening.
  • Patients who had used immunosuppressive agents locally within 1 week before screening or systemic immunosuppressive agents within 2 weeks before screening.
  • Patients with oral local or systemic use of glucocorticosteroids within 4 weeks prior to screening.
  • Patients who have taken anticholinergic drugs to reduce salivary secretion within 2 weeks prior to screening.
  • 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).
  • Patients with severe anemia (Hb < 60g/L).
  • 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.
  • Known or suspected allergic history or serious adverse reactions to the experimental drug and its excipients.
  • Pregnant or lactating women and those with recent pregnancy plans.
  • Participants who had participated in other interventional clinical trials within 3 months prior to screening.
  • Other conditions deemed inappropriate by the investigator for participation in the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Hospital of Hunan University of Chinese Medicine

    Changsha, Hunan, 410000

Other trials in China

About this study

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

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.

Conditions
Healthy
Being tested
GB001 recombinant peptide spray low dose group、high dose group, GB001 recombinant peptide spray placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GB001 recombinant peptide spray low dose group、high dose groupDrug

    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.

  • GB001 recombinant peptide spray placeboDrug

    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

Study groups in NCT06429566
Study groupRoleWhat they receive
GB001 recombinant peptide spray low dose groupExperimentalEach 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.
Receives: Drug: GB001 recombinant peptide spray low dose group、high dose group
GB001 recombinant peptide spray high dose groupExperimentalEach 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.
Receives: Drug: GB001 recombinant peptide spray low dose group、high dose group
Placebo groupExperimentalEach subject will take oral GB001 recombinant peptide spray 4 times a day, 4 sprays each time, for 8 days.
Receives: Drug: GB001 recombinant peptide spray placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Target ulcer healing rate for patients in 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.

    Measured: Day 6

  2. Subjects self-rated the time it took for irritation pain to disappear

    Measured: Day 8

Secondary outcomes (10)

  1. Time for target ulcer to heal

    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.

    Measured: Day 8

  2. Targeted ulcer healing rate for patients in day 4 and 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.

    Measured: Day 4,Day 8

  3. Changes in target ulcer area relative to baseline

    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.

    Measured: Day 4,Day 6,Day 8

  4. Self evaluation of pain disappearance rate and relief rate

    Measured: Day 4,Day 6,Day 8

  5. Pharmacokinetics Characteristics， t½ of GB001 Recombinant Peptide

    Apparent terminal phase half-life

    Measured: Day 1,Day 4

  6. Pharmacokinetics Characteristics，AUC of GB001 Recombinant Peptide

    Area under the plasma concentration versus time curve

    Measured: Day 1,Day 4

  7. Pharmacokinetics Characteristics， Cmax of GB001 Recombinant Peptide

    Maximum plasma concentration

    Measured: Day 1,Day 4

  8. Pharmacokinetics Characteristics， Tmax of GB001 Recombinant Peptide

    Time of maximum plasma concentration

    Measured: Day 1,Day 4

  9. Immunogenicity(drug resistant antibody (ADA))

    Measured: Day 1,Day 14,Day 28

  10. Incidence of Adverse Events

    Measured: First dose to last visit,an average of 1 month.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2024
  2. Study start18 Jul 2023
  3. Primary completion6 Dec 2023
  4. Study completion10 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06429566
Sponsor's protocol ID
YK2019L01P-IIa
Status last verified
Apr 2024
First submitted
30 Apr 2024
Last updated
9 Apr 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GB001 recombinant peptide spray low dose group、high dose group in people with Healthy, run by Zhejiang Echon Biopharm Limited at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target ulcer healing rate for patients in day 6 (time frame: Day 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06429566.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.

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