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This trial is conducted in China. The purpose of this clinical trial is to evaluate the safety and tolerability, pharmacokinetic (PK) characteristics, and immunogenicity of single/multiple inhalation of different doses of GB002 recombinant peptide in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Ascending Dose of GB002 Recombinant Peptide Inhalation Solution | Experimental | Each subject will receive one single administration of GB002 recombinant peptide inhalation solution. The dosage of each group is 0.625mg, 1.25mg, 2.5mg, 5.0mg,7.5mg, respectively. |
|
| Multiple Ascending Dose of GB002 Recombinant Peptide Inhalation Solution | Experimental | The subjects will receive multiple doses of GB002 recombinant peptide inhalation solution, administered twice a day for 6 consecutive days. The dosage for each group is 2.5mg, 5.0mg, and 6.5mg, respectively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GB002 Recombinant Peptide Inhalation Solution | Drug | Inhalation administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Day 1 to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma GB002 Recombinant Peptide concentrations | Day 1 to Day 7 | |
| Immunogenicity | Anti-drug antibody(ADA)and neutralizing antibody Nab | Day 14 and Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| GB002 Recombinant Peptide concentrations in induced sputum | Day 1 to Day 7 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Hospital of Changsha | Changsha | Hunan | 410015 | China |
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| Placebo | Drug | Inhalation administration |
|