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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06429566
• Other study ID #: YK2019L01P-IIa
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 18, 2023
• Est. completion date: July 10, 2024

Study information

• Verified date: April 2024
• Source: Zhejiang Echon Biopharm Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: July 10, 2024
• Est. primary completion date: December 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Stomatitis, Aphthous

Intervention

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.
• 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

Country	Name	City	State
China	The First Hospital of Hunan University of Chinese Medicine	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Echon Biopharm Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 6
Primary	Subjects self-rated the time it took for irritation pain to disappear		Day 8
Secondary	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.	Day 8
Secondary	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.	Day 4,Day 8
Secondary	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.	Day 4,Day 6,Day 8
Secondary	Self evaluation of pain disappearance rate and relief rate		Day 4,Day 6,Day 8
Secondary	Pharmacokinetics Characteristics, t½ of GB001 Recombinant Peptide	Apparent terminal phase half-life	Day 1,Day 4
Secondary	Pharmacokinetics Characteristics,AUC of GB001 Recombinant Peptide	Area under the plasma concentration versus time curve	Day 1,Day 4
Secondary	Pharmacokinetics Characteristics, Cmax of GB001 Recombinant Peptide	Maximum plasma concentration	Day 1,Day 4
Secondary	Pharmacokinetics Characteristics, Tmax of GB001 Recombinant Peptide	Time of maximum plasma concentration	Day 1,Day 4
Secondary	Immunogenicity(drug resistant antibody (ADA))		Day 1,Day 14,Day 28
Secondary	Incidence of Adverse Events		First dose to last visit,an average of 1 month.