ADPhase 1NCT03932916
Safety and Pharmacokinetic of Donepezil Pamoate in Healthy Subjects
A Phase 1 study testing Donepezil Pamoate for Injection 17mg, Donepezil Pamoate for Injection 34mg and Donepezil Hydrochloride 5mg in people with AD, 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
- AD
- What is being tested?
- Donepezil Pamoate for Injection 17mg, Donepezil Pamoate for Injection 34mg and Donepezil Hydrochloride 5mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 2 Jul 2019to 11 Sep 2020
- 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, 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
Who cannot join
- Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders
- Resting pulse rate <55/min or >100/min; Sitting systolic blood pressure <90mmHg or >140mmHg, diastolic blood pressure <60mmHg or >90mmHg
- ALT or Cr, BUN exceeding the upper limit of normal value; test results of urine protein was "++"
- 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
- Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody
- History or presence of drug or alcohol abuse
Show all 9Show fewer
- Positive pregnancy test result, or plan to be pregnant if female
- An unwillingness or inability to comply with food and beverage restrictions within 24 hours prior to dosing
- Participation in any other investigational drug trial within 30 days prior to screening.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai mental health center
Shanghai, Shanghai Municipality, 200030
About this study
Official title: Evaluation of Safety and Pharmacokinetic Profiles of a Single-dose HHT201 in Healthy Subjects
The objective of this study is to evaluate the safety and pharmacokinetic profiles of HHT201 in healthy subjects.
Read the detailed 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.
- Conditions
- AD
- Being tested
- Donepezil Pamoate for Injection 17mg, Donepezil Pamoate for Injection 34mg, Donepezil Hydrochloride 5mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donepezil Pamoate for Injection 17mgDrug
Also called HHT201
A dosage of 17mg HHT201 will be injected into the muscle in the gluteus once.
Donepezil Pamoate for Injection 34mgDrug
Also called HHT201
A dosage of 34mg HHT201 will be injected into the muscle in the gluteus once.
Donepezil Hydrochloride 5mgDrug
Also called Aricept
A tablet of 5mg Donepezil Hydrochloride will be administered once.
| Study group | Role | What they receive |
|---|---|---|
| experimental group 1 | Experimental | HHT201 17mg injection Receives: Drug: Donepezil Pamoate for Injection 17mg |
| experimental group 2 | Experimental | HHT201 34mg injection Receives: Drug: Donepezil Pamoate for Injection 34mg |
| experimental group 3 | Active comparator | Donepezil Hydrochloride oral tablet 5mg Receives: Drug: Donepezil Hydrochloride 5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of Donepezil
Maximum observed concentration of drug substance in plasma.
Measured: Blood samples collected over a 35 days period
Tmax of Donepezil
Time when the maximum concentration is acheived
Measured: Blood samples collected over a 35 days period
AUClast of Donepezil
Area under the concentration-time curve from time zero to time of last measurable concentration.
Measured: Blood samples collected over a 35 days period
AUC0-∞ of Donepezil
Area under the concentration-time curve from time zero to infinity.
Measured: Blood samples collected over a 35 days period
t1/2 of Donepezil
The time when the concentraion of the drug eliminated to half of the initial.
Measured: Blood samples collected over a 35 days period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start2 Jul 2019
- Primary completion6 Aug 2020
- Study completion11 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADStudies 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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Synergy Pharmaceutical Sciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huafang Li, PhD, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03932916
- Sponsor's protocol ID
- DON101-CTP
- Status last verified
- Sep 2020
- First submitted
- 23 Apr 2019
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Pharmacokinetic Profiles of a Single-dose HHT201 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03932916
- Acronym / sponsor ID
- DON101-CTP
- Conditions
- AD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Shanghai Synergy Pharmaceutical Sciences Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Jul 2019 (actual)
- Primary completion
- 6 Aug 2020 (actual)
- Study completion
- 11 Sep 2020 (actual)
- First posted
- 1 May 2019 (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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| experimental group 1 | Experimental | Drug: Donepezil Pamoate for Injection 17mgHHT201 17mg injection |
| experimental group 2 | Experimental | Drug: Donepezil Pamoate for Injection 34mgHHT201 34mg injection |
| experimental group 3 | Active comparator | Drug: Donepezil Hydrochloride 5mgDonepezil Hydrochloride oral tablet 5mg |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders
- Resting pulse rate <55/min or >100/min; Sitting systolic blood pressure <90mmHg or >140mmHg, diastolic blood pressure <60mmHg or >90mmHg
- ALT or Cr, BUN exceeding the upper limit of normal value; test results of urine protein was "++"
- 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
- Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody
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 Pamoate for Injection 17mgAlso: HHT201A dosage of 17mg HHT201 will be injected into the muscle in the gluteus once. | Drug | experimental group 1 |
| Donepezil Pamoate for Injection 34mgAlso: HHT201A dosage of 34mg HHT201 will be injected into the muscle in the gluteus once. | Drug | experimental group 2 |
| Donepezil Hydrochloride 5mgAlso: AriceptA tablet of 5mg Donepezil Hydrochloride will be administered once. | Drug | experimental group 3 |
Primary outcome
Cmax of Donepezil
Time frame: Blood samples collected over a 35 days period
Maximum observed concentration of drug substance in plasma.
Tmax of Donepezil
Time frame: Blood samples collected over a 35 days period
Time when the maximum concentration is acheived
AUClast of Donepezil
Time frame: Blood samples collected over a 35 days period
Area under the concentration-time curve from time zero to time of last measurable concentration.
AUC0-∞ of Donepezil
Time frame: Blood samples collected over a 35 days period
Area under the concentration-time curve from time zero to infinity.
t1/2 of Donepezil
Time frame: Blood samples collected over a 35 days period
The time when the concentraion of the drug eliminated to half of the initial.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
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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.
Huafang Li, PhD principal investigator
Shanghai Mental Health Center
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 Pamoate for Injection 17mg, Donepezil Pamoate for Injection 34mg and Donepezil Hydrochloride 5mg in people with AD, 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 9 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: finished, as of the sponsor's last update on 29 Sep 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax of Donepezil (time frame: Blood samples collected over a 35 days period). The study lists 5 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 29 Sep 2020.