A Single Dose Escalation Study of HHT201 in Healthy Subjects

A Single-center, Open-label, Single-dose Ascending Phase I Clinical Study Evaluating the Safety, Tolerability, and Pharmacokinetic Profile of HHT201 (Donepezil Dihydroxynaphthalate for Injection) in Healthy Subjects

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

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Zhe Jiang
      • Taizhou, Zhe Jiang, China, 318000
        • Zhejiang Province Taizhou Hospital Luqiao Hospital (Enze Hospital) (Taizhou Hospital Phase I Center)
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Chinese healthy subjects, both male and female;
  2. 20 years old ≤ 60 years old;
  3. The weight of women is not less than 45 kg, the weight of men is not less than 50 kg, and the BMI is between 19 and 28 (including the upper and lower limits);
  4. Understand and sign informed consent to participate in clinical trials voluntarily.

Exclusion Criteria:

  1. Patients with a history of cardiovascular, respiratory, liver, kidney, endocrine system, digestive system, blood and lymphatic system, immune system, nervous system, skeletal system, psychiatric and other major diseases, who were judged not suitable for participation in this study;
  2. Comprehensive physical examination, laboratory examination, vital signs, or past medical history are judged by clinicians to be abnormal and clinically significant;
  3. ALT or Cr, BUN beyond the upper limit of normal values; Urine protein test results were "++";
  4. Abnormal electrocardiogram (ECG) during the screening period had clinical significance, such as QTcF interval ≥450 ms in males and QTcF interval ≥470 ms in females, and the researchers considered it inappropriate to be included;
  5. Those who had used CYP3A4 inhibitors such as ketoconazole, itraconazole, erythromycin, or CYP2D6 inhibitors such as fluoxetine and quinidine within 30 days before the screening period, or rifampicin, phenytoin sodium, and carbamazil equal liver drug enzyme inducers, or had taken any prescription drugs, over-the-counter drugs, Chinese herbs, vitamins, or other dietary supplements within two weeks before enrollment;
  6. People who have taken food or drink (such as grapefruit) containing enzymes that can induce or inhibit liver metabolism within 1 week before the start of the trial;
  7. People who have a history of severe allergy or have a history of allergy to two or more drugs, or to any of the components of Donepezil dihydroxynaphthoate for injection;
  8. Patients with positive results of serum virology test [Hepatitis B surface antigen (HBsAg), Hepatitis Be antigen (HBeAg), hepatitis C virus antibody (HCV-IgG), human immunodeficiency virus (HIV) antibody, Treponema pallidum antibody (Anti-TP)];
  9. Subjects with smoking history within 2 weeks prior to the screening period or positive results of urine cotinine test during the admission review period;
  10. There is a history of alcohol abuse, or during the study period the subjects were unable to avoid drinking in the 24 hours before and during the trial drug administration, or those who tested positive for alcohol breath test;
  11. There is a history of drug abuse, and the drug screen test results are positive;
  12. Blood pregnancy test positive or breastfeeding women;
  13. Contraceptives in which the subject or his or her spouse has a family plan within the next 6 months after the last dose and is unable to use research-approved contraceptives during the study period as directed by the investigator;
  14. Blood donation or blood loss ≥400 mL in the 3 months before screening, blood donation ≥200 mL in the 1 month before screening;
  15. It is impossible to avoid the use of caffeinated beverages, vigorous exercise, or other factors affecting the absorption, distribution, metabolism, and excretion of the drug within 24 hours before and during the trial;
  16. Past or existing sick sinus syndrome or other supratrioventricular conduction heart disease such as sinus or atrioventricular block heart disease; Past or existing digestive tract ulcer, bladder outlet obstruction, history of asthma or obstructive pulmonary disease;
  17. Participants who have participated or are participating in other clinical trials within 3 months prior to screening;
  18. Subjects with other factors deemed unsuitable for participation in this study by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Single dose of 34 mg Donepezil Dihydroxynaphthalate for Injection.
HHT201 will be injected into the muscle of gluteus.
Other Names:
  • HHT201
Experimental: Group 2
Single dose of 68 mg Donepezil Dihydroxynaphthalate for Injection.
HHT201 will be injected into the muscle of gluteus.
Other Names:
  • HHT201
Experimental: Group 3
Single dose of 136 mg Donepezil Dihydroxynaphthalate for Injection.
HHT201 will be injected into the muscle of gluteus.
Other Names:
  • HHT201
Experimental: Group 4
Single dose of 204 mg Donepezil Dihydroxynaphthalate for Injection.
HHT201 will be injected into the muscle of gluteus.
Other Names:
  • HHT201
Experimental: Group 5
Single dose of 306 mg Donepezil Dihydroxynaphthalate for Injection.
HHT201 will be injected into the muscle of gluteus.
Other Names:
  • HHT201
Experimental: Group 6
Single dose of 408 mg Donepezil Dihydroxynaphthalate for Injection.
HHT201 will be injected into the muscle of gluteus.
Other Names:
  • HHT201

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: Up to 42 days
AEs and their incidence
Up to 42 days
Number of Participants With Abnormal Laboratory Values
Time Frame: Up to 42 days
Number of Participants With Abnormal Laboratory Values
Up to 42 days
Number of Participants With Abnormal ECG QT Interval
Time Frame: Up to 42 days
Number of Participants With Abnormal ECG QT Interval
Up to 42 days
Number of Participants With Abnormal Vital signs
Time Frame: Up to 42 days
Number of Participants With Abnormal Vital signs
Up to 42 days
Number of Participants With Abnormal Physical examination
Time Frame: Up to 42 days
It's comprehensive system check by the doctor.
Up to 42 days
VAS
Time Frame: Up to 42 days
Score of Visual Analogue Scale, which is a scale from 0-10, with higher scores indicate more severe.
Up to 42 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax of Donepezil
Time Frame: Blood samples collected over a 42-day period
Maximum observed concentration of drug substance in plasma.
Blood samples collected over a 42-day period
Tmax of Donepezil
Time Frame: Blood samples collected over a 42-day period
Time when the maximum concentration is acheived
Blood samples collected over a 42-day period
AUC0-t of Donepezil
Time Frame: Blood samples collected over a 42-day period
Area under the blood concentration-time curve from zero to the collection time t of the last measurable concentration.
Blood samples collected over a 42-day period
AUC0-∞ of Donepezil
Time Frame: Blood samples collected over a 42-day period
Area under the concentration-time curve from time zero to infinity.
Blood samples collected over a 42-day period
t1/2z of Donepezil
Time Frame: Blood samples collected over a 42-day period
The time when the concentraion of the drug eliminated to half of the initial.
Blood samples collected over a 42-day period
Vz/F
Time Frame: Blood samples collected over a 42-day period
Apparent volume of distribution
Blood samples collected over a 42-day period
CLz/F
Time Frame: Blood samples collected over a 42-day period
Apparent clearance
Blood samples collected over a 42-day period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Dongqing Lv, Zhejiang Taizhou Hospital Luqiao Hospital (Enze Hospital)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

March 19, 2024

First Submitted That Met QC Criteria

April 17, 2024

First Posted (Actual)

April 18, 2024

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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