A Single Dose Escalation Study of HHT201 in Healthy Subjects

NCT06373094 | Not Yet Recruiting Phase 1

• 1 other identifier: DON102-CTP
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (6)

• Adverse events

  AEs and their incidence

  Up to 42 days

• Number of Participants With Abnormal Laboratory Values

  Number of Participants With Abnormal Laboratory Values

  Up to 42 days

• Number of Participants With Abnormal ECG QT Interval

  Number of Participants With Abnormal ECG QT Interval

  Up to 42 days

• Number of Participants With Abnormal Vital signs

  Number of Participants With Abnormal Vital signs

  Up to 42 days

• Number of Participants With Abnormal Physical examination

  It's comprehensive system check by the doctor.

  Up to 42 days

• VAS

  Score of Visual Analogue Scale, which is a scale from 0-10, with higher scores indicate more severe.

  Up to 42 days

Secondary Outcomes (7)

• Cmax of Donepezil

  Blood samples collected over a 42-day period

• Tmax of Donepezil

  Blood samples collected over a 42-day period

• AUC0-t of Donepezil

  Blood samples collected over a 42-day period

• AUC0-∞ of Donepezil

  Blood samples collected over a 42-day period

• t1/2z of Donepezil

  Blood samples collected over a 42-day period

Study Arms (6)

Group 1

EXPERIMENTAL

Single dose of 34 mg Donepezil Dihydroxynaphthalate for Injection.

Drug: Donepezil Dihydroxynaphthalate for Injection

Group 2

EXPERIMENTAL

Single dose of 68 mg Donepezil Dihydroxynaphthalate for Injection.

Drug: Donepezil Dihydroxynaphthalate for Injection

Group 3

EXPERIMENTAL

Single dose of 136 mg Donepezil Dihydroxynaphthalate for Injection.

Drug: Donepezil Dihydroxynaphthalate for Injection

Group 4

EXPERIMENTAL

Single dose of 204 mg Donepezil Dihydroxynaphthalate for Injection.

Drug: Donepezil Dihydroxynaphthalate for Injection

Group 5

EXPERIMENTAL

Single dose of 306 mg Donepezil Dihydroxynaphthalate for Injection.

Drug: Donepezil Dihydroxynaphthalate for Injection

Group 6

EXPERIMENTAL

Single dose of 408 mg Donepezil Dihydroxynaphthalate for Injection.

Drug: Donepezil Dihydroxynaphthalate for Injection

Interventions

Donepezil Dihydroxynaphthalate for Injection DRUG

HHT201 will be injected into the muscle of gluteus.

Also known as: HHT201

Group 1; Group 2; Group 3; Group 4; Group 5; Group 6

Eligibility Criteria

• Age: 20 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Chinese healthy subjects, both male and female;
• years old ≤ 60 years old;
• 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);
• Understand and sign informed consent to participate in clinical trials voluntarily.

You may not qualify if:

• 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;
• Comprehensive physical examination, laboratory examination, vital signs, or past medical history are judged by clinicians to be abnormal and clinically significant;
• ALT or Cr, BUN beyond the upper limit of normal values; Urine protein test results were "++";
• 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;
• 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;
• 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;
• 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;
• Patients with positive results of serum virology test \[Hepatitis B surface antigen (HBsAg), Hepatitis Be antigen (HBeAg), hepatitis C virus antibody (HCV-IgG), human immunodeficiency virus (HIV) antibody, Treponema pallidum antibody (Anti-TP)\];
• Subjects with smoking history within 2 weeks prior to the screening period or positive results of urine cotinine test during the admission review period;
• 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;
• There is a history of drug abuse, and the drug screen test results are positive;
• Blood pregnancy test positive or breastfeeding women;
• 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;
• Blood donation or blood loss ≥400 mL in the 3 months before screening, blood donation ≥200 mL in the 1 month before screening;
• 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;

Sponsors & Collaborators

• Shanghai Synergy Pharmaceutical Sciences Co., Ltd.: lead

Study Sites (1)

Zhejiang Province Taizhou Hospital Luqiao Hospital (Enze Hospital) (Taizhou Hospital Phase I Center)

Taizhou, Zhejiang, 318000, China

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Injections

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Dongqing Lv

  Zhejiang Taizhou Hospital Luqiao Hospital (Enze Hospital)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dongqing Lv

CONTACT

86-0576-85199816; lvdq@enzemed.com

Zhanrong Ye

CONTACT

86-0576-85199816; Zoe.Ye@enzemed-crc.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: April 18, 2024
• Study Start: June 1, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)