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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
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.
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
The First Hospital of Hunan University of Chinese Medicine
Changsha, Hunan, China
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.
Time frame: Day 6
Subjects self-rated the time it took for irritation pain to disappear
Time frame: Day 8
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.
Time frame: Day 8
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.
Time frame: 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.
Time frame: Day 4,Day 6,Day 8
Self evaluation of pain disappearance rate and relief rate
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Time frame: Day 4,Day 6,Day 8
Pharmacokinetics Characteristics, t½ of GB001 Recombinant Peptide
Apparent terminal phase half-life
Time frame: Day 1,Day 4
Pharmacokinetics Characteristics,AUC of GB001 Recombinant Peptide
Area under the plasma concentration versus time curve
Time frame: Day 1,Day 4
Pharmacokinetics Characteristics, Cmax of GB001 Recombinant Peptide
Maximum plasma concentration
Time frame: Day 1,Day 4
Pharmacokinetics Characteristics, Tmax of GB001 Recombinant Peptide
Time of maximum plasma concentration
Time frame: Day 1,Day 4
Immunogenicity(drug resistant antibody (ADA))
Time frame: Day 1,Day 14,Day 28
Incidence of Adverse Events
Time frame: First dose to last visit,an average of 1 month.