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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose-escalation of GB001 recombinant peptide spray | Experimental | 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. |
|
| Oral retention time test for a single dose | Experimental | Each subject will receive one single administration of GB001 recombinant peptide. The dosage of the group is 0.108mg. |
|
| Multiple Ascending Dose of GB001 recombinant peptide spray | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GB001 recombinant peptide spray | Drug | administrated oral spray |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Oral retention time | Oral retention time | Up to 120 minute after first dose |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Feng Shao, MD | The First Affiliated Hospital with Nanjing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Nanjing medical University | Nanjing | Jiangsu | 210029 | China |
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| Placebo | Drug | administrated oral spray |
|
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 |