The objective of this study is to evaluate the safety and pharmacokinetic profiles of HHT201 in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
HHT201 will be injected into the muscle of gluteus.
Zhejiang Province Taizhou Hospital Luqiao Hospital (Enze Hospital) (Taizhou Hospital Phase I Center)
Taizhou, Zhejiang, China
Adverse events
AEs and their incidence
Time frame: Up to 42 days
Number of Participants With Abnormal Laboratory Values
Number of Participants With Abnormal Laboratory Values
Time frame: Up to 42 days
Number of Participants With Abnormal ECG QT Interval
Number of Participants With Abnormal ECG QT Interval
Time frame: Up to 42 days
Number of Participants With Abnormal Vital signs
Number of Participants With Abnormal Vital signs
Time frame: Up to 42 days
Number of Participants With Abnormal Physical examination
It's comprehensive system check by the doctor.
Time frame: Up to 42 days
VAS
Score of Visual Analogue Scale, which is a scale from 0-10, with higher scores indicate more severe.
Time frame: Up to 42 days
Cmax of Donepezil
Maximum observed concentration of drug substance in plasma.
Time frame: Blood samples collected over a 42-day period
Tmax of Donepezil
Time when the maximum concentration is acheived
Time frame: Blood samples collected over a 42-day period
AUC0-t of Donepezil
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Area under the blood concentration-time curve from zero to the collection time t of the last measurable concentration.
Time frame: Blood samples collected over a 42-day period
AUC0-∞ of Donepezil
Area under the concentration-time curve from time zero to infinity.
Time frame: Blood samples collected over a 42-day period
t1/2z of Donepezil
The time when the concentraion of the drug eliminated to half of the initial.
Time frame: Blood samples collected over a 42-day period
Vz/F
Apparent volume of distribution
Time frame: Blood samples collected over a 42-day period
CLz/F
Apparent clearance
Time frame: Blood samples collected over a 42-day period