Safety,Tolerability,and Pharmacokinetics Profiles of GB001 Recombinant Peptide Spray in Healthy Subjects

Study Overview
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Brief Summary
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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.

Official Title
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A PhaseⅠRandomised, Double-blind, Placebo-controlled, Study to Evaluate the Safety, Tolerability, and Pharmacokinetics Characteristics of the Oral Topical Use of GB001 Recombinant Peptide Spray in Chinese Healthy Adult Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: GB001 recombinant peptide spray
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). 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. 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. 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: Those allergic to GB001 peptide or any other drugs, or suffered from allergic disease or allergic constitution. 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. Subjects has obvious oral lesions or diseases, such as erosion of oral mucosa, ulcer or obvious periodontitis. 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. Subject who smoke more than 10 cigarettes per day or is unwilling to stop smoking whenever required for the trial procedure. Subject with a history of drug abuse, or those with positive urine screening test for drug abuse. 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. Blood loss or blood donation more than 400 mL within 90 days prior to screening. Received major surgery within 90 days prior to screening, or participated in any other drug/device clinical trial. Pregnant or lactating women; or female subject of childbearing age have a positive serum pregnancy test result during the screening. Subject with dizzy needle or difficulty in venous blood collection. Subject unsuitable for the trial in the judgement of the investigator.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single dose-escalation of GB001 recombinant peptide spray<br>Each subject will receive one single administration of GB001 recombinant peptide. The dosage of each group is 0.054mg, 0.108mg, 0.216mg, 0.432mg and 0.864mg, respectively. | Drug: GB001 recombinant peptide spray<br>* administrated oral spray<br>Drug: Placebo<br>* administrated oral spray<br>|
| Experimental: Oral retention time test for a single dose<br>Each subject will receive one single administration of GB001 recombinant peptide. The dosage of the group is 0.108mg. | Drug: GB001 recombinant peptide spray<br>* administrated oral spray<br>|
| Experimental: Multiple Ascending Dose of GB001 recombinant peptide spray<br>Each subject will be dosed with oral spray of GB001 recombinant peptide ten times per day for four days. GB001 recombinant peptide will be administrated, and the dosage of each group is 0.108mg, 0.216mg and 0.432mg, respectively. | Drug: GB001 recombinant peptide spray<br>* administrated oral spray<br>Drug: Placebo<br>* administrated oral spray<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events | 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 | Through the study completion, an average of 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics Characteristics， t½ of GB001 recombinant peptide | Apparent terminal phase half-life | Up to 240 minutes after last dose | 
| Pharmacokinetics Characteristics , Cmax of GB001 recombinant peptide | Maximum plasma concentration | Up to 240 minutes after last dose | 
| Pharmacokinetics Characteristics , Tmax of GB001 recombinant peptide | Time of maximum plasma concentration | Up to 240 minutes after last dose | 
| Pharmacokinetics Characteristics , AUC of GB001 recombinant peptide | Area under the plasma concentration versus time curve | Up to 240 minutes after last dose | 
| Pharmacokinetics Characteristics , Vd of GB001 recombinant peptide | Apparent distribution volume | Up to 240 minutes after last dose | 
| Pharmacokinetics Characteristics , Ctrough of GB001 recombinant peptide | Trough plasma concentration | Up to 240 minutes after last dose |