Healthy
Conditions
Brief summary
This trial is conducted in China. The aim of this clinical trial is to assess the safety , tolerability and pharmacokinetics profiles of GB001 by single ascending dose and multiple ascending doses in healthy subjects after topical buccal delivery.
Interventions
DRUGGB001 recombinant peptide spray
administrated oral spray
DRUGPlacebo
administrated oral spray
Sponsors
Zhejiang Echon Biopharm Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy males or females aged 18 to 45 years, with a body mass index(BMI) 19-26kg/m2 and body weight no less than 45 kg (female) or 50 kg (male). 2. The results in the screening examinations (including general physical examination, vital signs, laboratory examinations, electrocardiogram, chest radiograph, etc.) are in the normal range, or are abnormal without clinical significance assessed by the investigator. 3. Subjects and their sexual partners agree to take effective contraceptive measures during the study period and at least 3 days after the end of the study. 4. Understanding and willing to comply strictly with the clinical trial protocol, complete all test procedures required in this trial, understand and sign informed consent form.
Exclusion criteria
1. Those allergic to GB001 peptide or any other drugs, or suffered from allergic disease or allergic constitution. 2. Any obvious clinical symptoms or abnormal test results with clinical significance suggested organ or system illness, unsuitable for inclusion in this trial in the investigator's judgement. 3. Subjects has obvious oral lesions or diseases, such as erosion of oral mucosa, ulcer or obvious periodontitis. 4. The weekly alcohol intake in 90 days before screening is more than 21 units (male) and more than 14 units (female) , or the subject is unwilling to stop drinking whenever required for the trial procedure. 5. Subject who smoke more than 10 cigarettes per day or is unwilling to stop smoking whenever required for the trial procedure. 6. Subject with a history of drug abuse, or those with positive urine screening test for drug abuse. 7. Subject who use of any other drugs within 30 days prior to screening, including prescription drugs, non-prescription drugs, biologicals, vitamins, minerals and nutritional supplements. 8. Blood loss or blood donation more than 400 mL within 90 days prior to screening. 9. Received major surgery within 90 days prior to screening, or participated in any other drug/device clinical trial. 10. Pregnant or lactating women; or female subject of childbearing age have a positive serum pregnancy test result during the screening. 11. Subject with dizzy needle or difficulty in venous blood collection. 12. Subject unsuitable for the trial in the judgement of the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | Through the study completion, an average of 2 weeks | The number and the incidence of serious and non-serious adverse events observed in each treatment will be used to assess the safety and tolerability |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics Characteristics， t½ of GB001 recombinant peptide | Up to 240 minutes after last dose | Apparent terminal phase half-life |
| Pharmacokinetics Characteristics , Tmax of GB001 recombinant peptide | Up to 240 minutes after last dose | Time of maximum plasma concentration |
| Pharmacokinetics Characteristics , Cmax of GB001 recombinant peptide | Up to 240 minutes after last dose | Maximum plasma concentration |
| Pharmacokinetics Characteristics , Vd of GB001 recombinant peptide | Up to 240 minutes after last dose | Apparent distribution volume |
| Pharmacokinetics Characteristics , Ctrough of GB001 recombinant peptide | Up to 240 minutes after last dose | Trough plasma concentration |
| Pharmacokinetics Characteristics , AUC of GB001 recombinant peptide | Up to 240 minutes after last dose | Area under the plasma concentration versus time curve |
Other
| Measure | Time frame | Description |
|---|---|---|
| Oral retention time | Up to 120 minute after first dose | Oral retention time |
Countries
China
Outcome results
None listed