The objective of this study is to evaluate the safety and pharmacokinetic profiles of HHT201 in healthy subjects.
The study aims to evaluate the safety, pharmacokinetics and to determine the potential dose limiting toxicity of HHT201 in healthy subjects between the ages of 20-59, 6 in 17mg dose group and 20 in 34mg dose group. Another 12 subjects will be administered a tablet of 5mg Donepezil Hydrochloride to get the PK profile of Donepezil as reference. Eligible subjects will be accepted into the protocol after review and providing voluntary written informed consent forms and completion of a comprehensive medical, physical examination, and routine laboratory assessment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
38
A dosage of 17mg HHT201 will be injected into the muscle in the gluteus once.
A dosage of 34mg HHT201 will be injected into the muscle in the gluteus once.
A tablet of 5mg Donepezil Hydrochloride will be administered once.
Shanghai mental health center
Shanghai, Shanghai Municipality, China
Cmax of Donepezil
Maximum observed concentration of drug substance in plasma.
Time frame: Blood samples collected over a 35 days period
Tmax of Donepezil
Time when the maximum concentration is acheived
Time frame: Blood samples collected over a 35 days period
AUClast of Donepezil
Area under the concentration-time curve from time zero to time of last measurable concentration.
Time frame: Blood samples collected over a 35 days period
AUC0-∞ of Donepezil
Area under the concentration-time curve from time zero to infinity.
Time frame: Blood samples collected over a 35 days period
t1/2 of Donepezil
The time when the concentraion of the drug eliminated to half of the initial.
Time frame: Blood samples collected over a 35 days period
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