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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GB001 recombinant peptide spray low dose group | Experimental | 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. |
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| GB001 recombinant peptide spray high dose group | Experimental | 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. |
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| Placebo group | Experimental | Each subject will take oral GB001 recombinant peptide spray 4 times a day, 4 sprays each time, for 8 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GB001 recombinant peptide spray low dose group、high dose group | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Subjects self-rated the time it took for irritation pain to disappear | Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Targeted ulcer healing rate for patients in day 4 and day 8 |
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Inclusion Criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Hunan University of Chinese Medicine | Changsha | Hunan | 410000 | China |
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| GB001 recombinant peptide spray placebo | Drug | 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 |
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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 | 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 | Day 4,Day 6,Day 8 |
| Pharmacokinetics Characteristics, t½ of GB001 Recombinant Peptide | Apparent terminal phase half-life | Day 1,Day 4 |
| Pharmacokinetics Characteristics,AUC of GB001 Recombinant Peptide | Area under the plasma concentration versus time curve | Day 1,Day 4 |
| Pharmacokinetics Characteristics, Cmax of GB001 Recombinant Peptide | Maximum plasma concentration | Day 1,Day 4 |
| Pharmacokinetics Characteristics, Tmax of GB001 Recombinant Peptide | Time of maximum plasma concentration | Day 1,Day 4 |
| Immunogenicity(drug resistant antibody (ADA)) | Day 1,Day 14,Day 28 |
| Incidence of Adverse Events | First dose to last visit,an average of 1 month. |