## Protocol Section
### Identification Module
**NCT ID:** NCT06429566

**Brief Title:** Clinical Study of GB001 Recombinant Polypeptide Spray IIa Patients

**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

#### Organization Study ID Info
**ID:** YK2019L01P-IIa
#### Organization
**Class:** INDUSTRY
**Full Name:** Zhejiang Echon Biopharm Limited
### Status Module
#### Completion Date
**Date:** 2024-07-10

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2023-12-06

**Type:** ACTUAL

#### Start Date
**Date:** 2023-07-18

**Type:** ACTUAL

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-30
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Zhejiang Echon Biopharm Limited

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief 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.

### Conditions Module

**Conditions:**

- Healthy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 120

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Drug: GB001 recombinant peptide spray low dose group、high dose group

**Label:** GB001 recombinant peptide spray low dose group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Drug: GB001 recombinant peptide spray low dose group、high dose group

**Label:** GB001 recombinant peptide spray high dose group

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Each subject will take oral GB001 recombinant peptide spray 4 times a day, 4 sprays each time, for 8 days.

**Intervention Names:**

- Drug: GB001 recombinant peptide spray placebo

**Label:** Placebo group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- GB001 recombinant peptide spray high dose group

- GB001 recombinant peptide spray low dose group

**Description:** 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.

**Name:** GB001 recombinant peptide spray low dose group、high dose group

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo group

**Description:** 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

**Name:** GB001 recombinant peptide spray placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Target ulcer healing rate for patients in day 6

**Time Frame:** Day 6

**Measure:** Subjects self-rated the time it took for irritation pain to disappear

**Time Frame:** Day 8

#### Secondary Outcomes

**Description:** 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.

**Measure:** Time for target ulcer to heal

**Time Frame:** Day 8

**Description:** 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.

**Measure:** Targeted ulcer healing rate for patients in day 4 and day 8

**Time Frame:** Day 4,Day 8

**Description:** 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.

**Measure:** Changes in target ulcer area relative to baseline

**Time Frame:** Day 4,Day 6,Day 8

**Measure:** Self evaluation of pain disappearance rate and relief rate

**Time Frame:** Day 4,Day 6,Day 8

**Description:** Apparent terminal phase half-life

**Measure:** Pharmacokinetics Characteristics， t½ of GB001 Recombinant Peptide

**Time Frame:** Day 1,Day 4

**Description:** Area under the plasma concentration versus time curve

**Measure:** Pharmacokinetics Characteristics，AUC of GB001 Recombinant Peptide

**Time Frame:** Day 1,Day 4

**Description:** Maximum plasma concentration

**Measure:** Pharmacokinetics Characteristics， Cmax of GB001 Recombinant Peptide

**Time Frame:** Day 1,Day 4

**Description:** Time of maximum plasma concentration

**Measure:** Pharmacokinetics Characteristics， Tmax of GB001 Recombinant Peptide

**Time Frame:** Day 1,Day 4

**Measure:** Immunogenicity(drug resistant antibody (ADA))

**Time Frame:** Day 1,Day 14,Day 28

**Measure:** Incidence of Adverse Events

**Time Frame:** First dose to last visit,an average of 1 month.

### Eligibility Module

**Eligibility Criteria:** 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.

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Changsha

**Country:** China

**Facility:** The First Hospital of Hunan University of Chinese Medicine

**State:** Hunan

**Zip:** 410000

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M17206

- Name: Ulcer

- Relevance: LOW

- As Found: Unknown

- ID: M14850

- Name: Recurrence

- Relevance: LOW

- As Found: Unknown

- ID: M16071

- Name: Stomatitis, Aphthous

- Relevance: LOW

- As Found: Unknown

- ID: T455

- Name: Aphthous Stomatitis

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
