Safety and Pharmacokinetic of Donepezil Pamoate in Healthy Subjects

Shanghai Synergy Pharmaceutical Sciences

Status and phase: Completed; Phase 1

Conditions: AD

Treatments: Drug: Donepezil Hydrochloride 5mg; Drug: Donepezil Pamoate for Injection 17mg; Drug: Donepezil Pamoate for Injection 34mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03932916

DON101-CTP

Details and patient eligibility

About

The objective of this study is to evaluate the safety and pharmacokinetic profiles of HHT201 in healthy subjects.

Full description

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.

Enrollment: 38 patients

Sex: All

Ages: 20 to 59 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

1. Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders
2. Resting pulse rate <55/min or >100/min; Sitting systolic blood pressure <90mmHg or >140mmHg, diastolic blood pressure <60mmHg or >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 screening.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

38 participants in 3 patient groups

experimental group 1

Experimental group

Description:

HHT201 17mg injection

Treatment:

Drug: Donepezil Pamoate for Injection 17mg

experimental group 2

Experimental group

Description:

HHT201 34mg injection

Treatment:

Drug: Donepezil Pamoate for Injection 34mg

experimental group 3

Active Comparator group

Description:

Donepezil Hydrochloride oral tablet 5mg

Treatment:

Drug: Donepezil Hydrochloride 5mg