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
Overview
- Phase
- Phase 2
- Intervention
- GB001 recombinant peptide spray low dose group、high dose group
- Conditions
- Healthy
- Sponsor
- Zhejiang Echon Biopharm Limited
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Target ulcer healing rate for patients in day 6
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •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.
- •Exclusion criteria:
- •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.
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: GB001 recombinant peptide spray low dose group、high dose group
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.
Intervention: GB001 recombinant peptide spray low dose group、high dose group
Placebo group
Each subject will take oral GB001 recombinant peptide spray 4 times a day, 4 sprays each time, for 8 days.
Intervention: GB001 recombinant peptide spray placebo
Outcomes
Primary Outcomes
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.
Subjects self-rated the time it took for irritation pain to disappear
Time Frame: Day 8
Secondary Outcomes
- Time for target ulcer to heal(Day 8)
- Immunogenicity(drug resistant antibody (ADA))(Day 1,Day 14,Day 28)
- Targeted ulcer healing rate for patients in day 4 and day 8(Day 4,Day 8)
- Pharmacokinetics Characteristics， Cmax of GB001 Recombinant Peptide(Day 1,Day 4)
- Pharmacokinetics Characteristics， Tmax of GB001 Recombinant Peptide(Day 1,Day 4)
- Pharmacokinetics Characteristics， t½ of GB001 Recombinant Peptide(Day 1,Day 4)
- Pharmacokinetics Characteristics，AUC of GB001 Recombinant Peptide(Day 1,Day 4)
- Incidence of Adverse Events(First dose to last visit,an average of 1 month.)
- Changes in target ulcer area relative to baseline(Day 4,Day 6,Day 8)
- Self evaluation of pain disappearance rate and relief rate(Day 4,Day 6,Day 8)