- Solid Tumors
- Pipeline Molecules
- Alliance Partners
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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03932916
Recruitment Status Completed
First Posted May 1, 2019
Last update posted September 29, 2020
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.
|Experimental: experimental group 1
HHT201 17mg injection
Drug: Donepezil Pamoate for Injection 17mg
A dosage of 17mg HHT201 will be injected into the muscle in the gluteus once.
|Experimental: experimental group 2
HHT201 34mg injection
Drug: Donepezil Pamoate for Injection 34mg
A dosage of 34mg HHT201 will be injected into the muscle in the gluteus once.
|Active Comparator: experimental group 3
Donepezil Hydrochloride oral tablet 5mg
Drug: Donepezil Hydrochloride 5mg
A tablet of 5mg Donepezil Hydrochloride will be administered once.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
- Chinese healthy subjects, male or female
- between the ages of 20 and 60 years
- A body mass index (BMI), calculated as weight in kg/(height in m)², from 19 to 28
kg/m², and female weight≥45kg, male weight≥50kg
- Able to provide written informed consent forms
1. Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal,
endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic,
immunologic, lipid metabolism disorders
2. Resting pulse rate 100/min; Sitting systolic blood pressure 140mmHg, diastolic blood pressure 90mmHg
3. ALT or Cr, BUN exceeding the upper limit of normal value; test results of urine
protein was "++"
4. Clinically significant ECG abnormalities in screening or baseline, such as male QTc
interval ≥450ms and female QTc interval ≥470ms, and were considered inappropriate for
inclusion by the researchers
5. Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface
antigen (HBsAg), or hepatitis C antibody
6. History or presence of drug or alcohol abuse
7. Positive pregnancy test result, or plan to be pregnant if female
8. An unwillingness or inability to comply with food and beverage restrictions within 24
hours prior to dosing
9. Participation in any other investigational drug trial within 30 days prior to
Shanghai mental health center
Shanghai Synergy Pharmaceutical Sciences Co., Ltd.
Principal Investigator: Huafang Li, PhD Shanghai Mental Health Center