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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
91
administrated oral spray
administrated oral spray
The First Affiliated Hospital of Nanjing medical University
Nanjing, Jiangsu, China
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
Time frame: Through the study completion, an average of 2 weeks
Pharmacokinetics Characteristics, t½ of GB001 recombinant peptide
Apparent terminal phase half-life
Time frame: Up to 240 minutes after last dose
Pharmacokinetics Characteristics , Cmax of GB001 recombinant peptide
Maximum plasma concentration
Time frame: Up to 240 minutes after last dose
Pharmacokinetics Characteristics , Tmax of GB001 recombinant peptide
Time of maximum plasma concentration
Time frame: Up to 240 minutes after last dose
Pharmacokinetics Characteristics , AUC of GB001 recombinant peptide
Area under the plasma concentration versus time curve
Time frame: Up to 240 minutes after last dose
Pharmacokinetics Characteristics , Vd of GB001 recombinant peptide
Apparent distribution volume
Time frame: Up to 240 minutes after last dose
Pharmacokinetics Characteristics , Ctrough of GB001 recombinant peptide
Trough plasma concentration
Time frame: Up to 240 minutes after last dose
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