Alzheimer DiseasePhase 1NCT06373094
A Single Dose Escalation Study of HHT201 in Healthy Subjects
A Phase 1 study testing Donepezil Dihydroxynaphthalate for Injection in people with Alzheimer Disease, run by Shanghai Synergy Pharmaceutical Sciences Co., Ltd. at 1 site in China.
Trial summary
The objective of this study is to evaluate the safety and pharmacokinetic profiles of HHT201 in healthy subjects. Read more about this study
- Who is it for?
- Ages 20 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Donepezil Dihydroxynaphthalate for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 31 Mar 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Chinese healthy subjects, both male and female;
- 20 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.
Who cannot join
- 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;
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- 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;
- 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;
- Participants who have participated or are participating in other clinical trials within 3 months prior to screening;
- Subjects with other factors deemed unsuitable for participation in this study by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhejiang Province Taizhou Hospital Luqiao Hospital (Enze Hospital) (Taizhou Hospital Phase I Center)
Taizhou, Zhejiang, 318000
Donqing Lv, 86-0576-85199816, lvdq@enzemed.com
Zhanrong Ye, 86-0576-85199816, Zoe.Ye@enzemed-crc.com
About this study
Official title: 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.
- Conditions
- Alzheimer Disease
- Being tested
- Donepezil Dihydroxynaphthalate for Injection
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donepezil Dihydroxynaphthalate for InjectionDrug
Also called HHT201
HHT201 will be injected into the muscle of gluteus.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Single dose of 34 mg Donepezil Dihydroxynaphthalate for Injection. Receives: Drug: Donepezil Dihydroxynaphthalate for Injection |
| Group 2 | Experimental | Single dose of 68 mg Donepezil Dihydroxynaphthalate for Injection. Receives: Drug: Donepezil Dihydroxynaphthalate for Injection |
| Group 3 | Experimental | Single dose of 136 mg Donepezil Dihydroxynaphthalate for Injection. Receives: Drug: Donepezil Dihydroxynaphthalate for Injection |
| Group 4 | Experimental | Single dose of 204 mg Donepezil Dihydroxynaphthalate for Injection. Receives: Drug: Donepezil Dihydroxynaphthalate for Injection |
| Group 5 | Experimental | Single dose of 306 mg Donepezil Dihydroxynaphthalate for Injection. Receives: Drug: Donepezil Dihydroxynaphthalate for Injection |
| Group 6 | Experimental | Single dose of 408 mg Donepezil Dihydroxynaphthalate for Injection. Receives: Drug: Donepezil Dihydroxynaphthalate for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
AEs and their incidence
Measured: Up to 42 days
Number of Participants With Abnormal Laboratory Values
Number of Participants With Abnormal Laboratory Values
Measured: Up to 42 days
Number of Participants With Abnormal ECG QT Interval
Number of Participants With Abnormal ECG QT Interval
Measured: Up to 42 days
Number of Participants With Abnormal Vital signs
Number of Participants With Abnormal Vital signs
Measured: Up to 42 days
Number of Participants With Abnormal Physical examination
It's comprehensive system check by the doctor.
Measured: Up to 42 days
VAS
Score of Visual Analogue Scale, which is a scale from 0-10, with higher scores indicate more severe.
Measured: Up to 42 days
Secondary outcomes (7)
Cmax of Donepezil
Maximum observed concentration of drug substance in plasma.
Measured: Blood samples collected over a 42-day period
Tmax of Donepezil
Time when the maximum concentration is acheived
Measured: Blood samples collected over a 42-day period
AUC0-t of Donepezil
Area under the blood concentration-time curve from zero to the collection time t of the last measurable concentration.
Measured: Blood samples collected over a 42-day period
AUC0-∞ of Donepezil
Area under the concentration-time curve from time zero to infinity.
Measured: Blood samples collected over a 42-day period
t1/2z of Donepezil
The time when the concentraion of the drug eliminated to half of the initial.
Measured: Blood samples collected over a 42-day period
Vz/F
Apparent volume of distribution
Measured: Blood samples collected over a 42-day period
CLz/F
Apparent clearance
Measured: Blood samples collected over a 42-day period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start1 Jun 2024 (estimated)
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Synergy Pharmaceutical Sciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dongqing Lv, Principal investigator, Zhejiang Taizhou Hospital Luqiao Hospital (Enze Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06373094
- Sponsor's protocol ID
- DON102-CTP
- Status last verified
- Apr 2024
- First submitted
- 19 Mar 2024
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06373094
- Acronym / sponsor ID
- DON102-CTP
- Conditions
- Alzheimer Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Shanghai Synergy Pharmaceutical Sciences Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the safety and pharmacokinetic profiles of HHT201 in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Donepezil Dihydroxynaphthalate for InjectionSingle dose of 34 mg Donepezil Dihydroxynaphthalate for Injection. |
| Group 2 | Experimental | Drug: Donepezil Dihydroxynaphthalate for InjectionSingle dose of 68 mg Donepezil Dihydroxynaphthalate for Injection. |
| Group 3 | Experimental | Drug: Donepezil Dihydroxynaphthalate for InjectionSingle dose of 136 mg Donepezil Dihydroxynaphthalate for Injection. |
| Group 4 | Experimental | Drug: Donepezil Dihydroxynaphthalate for InjectionSingle dose of 204 mg Donepezil Dihydroxynaphthalate for Injection. |
| Group 5 | Experimental | Drug: Donepezil Dihydroxynaphthalate for InjectionSingle dose of 306 mg Donepezil Dihydroxynaphthalate for Injection. |
| Group 6 | Experimental | Drug: Donepezil Dihydroxynaphthalate for InjectionSingle dose of 408 mg Donepezil Dihydroxynaphthalate for Injection. |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Chinese healthy subjects, both male and female;
- 20 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.
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Donepezil Dihydroxynaphthalate for InjectionAlso: HHT201HHT201 will be injected into the muscle of gluteus. | Drug | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
Primary outcome
Adverse events
Time frame: Up to 42 days
AEs and their incidence
Number of Participants With Abnormal Laboratory Values
Time frame: Up to 42 days
Number of Participants With Abnormal Laboratory Values
Number of Participants With Abnormal ECG QT Interval
Time frame: Up to 42 days
Number of Participants With Abnormal ECG QT Interval
Number of Participants With Abnormal Vital signs
Time frame: Up to 42 days
Number of Participants With Abnormal Vital signs
Number of Participants With Abnormal Physical examination
Time frame: Up to 42 days
It's comprehensive system check by the doctor.
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.
7 secondary outcomes
Cmax of Donepezil
Time frame: Blood samples collected over a 42-day period
Tmax of Donepezil
Time frame: Blood samples collected over a 42-day period
AUC0-t of Donepezil
Time frame: Blood samples collected over a 42-day period
AUC0-∞ of Donepezil
Time frame: Blood samples collected over a 42-day period
t1/2z of Donepezil
Time frame: Blood samples collected over a 42-day period
Vz/F
Time frame: Blood samples collected over a 42-day period
CLz/F
Time frame: Blood samples collected over a 42-day period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dongqing Lv principal investigator
Zhejiang Taizhou Hospital Luqiao Hospital (Enze Hospital)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Donepezil Dihydroxynaphthalate for Injection in people with Alzheimer Disease, run by Shanghai Synergy Pharmaceutical Sciences Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dongqing Lv (86-0576-85199816, lvdq@enzemed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: Up to 42 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.