Alzheimer DiseasePhase 1/2NCT05345509
A Clinical Trial to Access Pharmacokinetic Profiles and Safety of IVL3003.
A Phase 1/2 study testing Aricept Tablet and IVL3003 in people with Alzheimer Disease, run by Inventage Lab., Inc. at 1 site in Australia.
Trial summary
A Clinical Trial to Assess Pharmacokinetic Profiles and Safety of IVL3003 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Aricept Tablet and IVL3003
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Apr 2023to 13 Nov 2025
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female, ≥18 and ≤55 years of age, non-smokers or occasional smokers (defined as smoking less than 10 cigarettes or nicotine equivalent per week, and willing to abstain from smoking during confinement at the study site).
- Body mass index (BMI) ≥18.0 and ≤32.0 kg/m2 and body weight ≥55.0 kg for males and ≥50.0 kg for females.
- Male subjects who are sexually active with a same-sex partner must be willing to use a condom until study exit.
- Male and female subjects who practice abstinence from sexual intercourse as a usual and preferred lifestyle.
- Willing to abstain from use of non-steroidal anti-inflammatory drugs (NSAIDs) including ibuprofen, naproxen, aspirin, meloxicam, etc. from screening until study exit.
- Willing and able to provide written informed consent after the nature of the study has been explained and prior to the commencement of any protocol specific study procedures.
Who cannot join
- Any clinically significant abnormal finding at physical examination at screening.
- Clinically significant abnormal laboratory test results or positive serology test results for human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus at screening.
- Positive pregnancy test at screening or Day -1 or lactating female subject.
- Positive drug or alcohol screen at screening or Day -1.
- Any history of malignancy or neoplastic disease.
- History of significant allergic reactions (e.g., drug reaction, anaphylactic reaction, hypersensitivity, angioedema) to donepezil, piperidine derivatives, dimenhydrinate or derivatives, benzatropine or derivatives, or other related drugs, or to any excipient present in the formulation for any study drug.
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- Presence of hereditary disorders including galactose intolerance, lactase deficiency, and glucose-galactose malabsorption (for Part B only).
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin >1.5x the upper limit of normal (ULN) at screening or Day -1.
- Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2 as calculated by the 2021 Chronic Kidney Disease-Epidemiology (CKD-EPI) equation at screening or Day -1.
- Clinically significant ECG abnormalities (QTc >450 ms or PR interval >220 ms) or vital sign abnormalities (systolic blood pressure <90 or >140 mmHg, diastolic blood pressure <40 or >90 mmHg, or heart rate <50 or >100 bpm) at screening or Day 1.
- History of significant bradycardia or atrioventricular (AV) block.
- History of significant asthma (except for fully resolved childhood asthma) or chronic obstructive pulmonary disease (COPD).
- History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 14 units of alcohol per week (1 unit = 375 mL of beer 3.5%, 100 mL of wine 13.5%, or 30 mL of spirit 40%).
- History of drug abuse within 1 year prior to screening or recreational use of soft drugs (such as marijuana) or hard drugs (such as cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin, and amphetamine derivatives) within 1 month, or use of codeine within 3 months prior to screening.
- Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 30 days prior to dosing.
- Consumption of high levels of caffeine (equivalent to 3 regular cups of coffee or 2 energy drinks, per day).
- Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Open-Label, Exploratory, Sequential, Pharmacokinetic Single Ascending Dose Study of IVL3003 Versus Multiple Doses of Aricept (Donepezil) Tablets in Healthy Subjects
A Clinical Trial to Assess Pharmacokinetic Profiles and Safety of IVL3003
Read the detailed description
A Phase 1, Randomized, Open-Label, Exploratory, Sequential, Pharmacokinetic Single Ascending Dose Study of IVL3003 Versus Multiple Doses of Aricept (Donepezil) Tablets in Healthy Subjects
- Conditions
- Alzheimer Disease
- Being tested
- Aricept Tablet, IVL3003
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aricept TabletDrug
Donepezil Tablet once daily P.O
IVL3003Drug
Donepezil Long-Acting Injection, once S.C Injection
IVL3003Drug
Donepezil Long-Acting Injection, once IM Injection
| Study group | Role | What they receive |
|---|---|---|
| Aricept Tablet | Active comparator | Aricept Tablet, QD, PO Receives: Drug: Aricept Tablet |
| IVL3003 (A mg) | Experimental | SC, Single Dose Receives: Drug: IVL3003 |
| IVL3003 (B mg) | Experimental | SC, Single Dose Receives: Drug: IVL3003 |
| IVL3003 (C mg) | Experimental | SC, Single Dose Receives: Drug: IVL3003 |
| IVL3003 (Dmg) | Experimental | Intramuscular Receives: Drug: IVL3003 |
| IVL3003 (Emg) | Experimental | Intramuscular Receives: Drug: IVL3003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUClast of IVL3003
Area under the concentration-time curve from time zero to last
Measured: Pre-dose, up to 1month
AUCinf of IVL3003
Area under the concentration-time curve from time zero to infinity
Measured: Pre-dose, up to 1month
AUClast of Aricept
Area under the concentration-time curve from time zero to last
Measured: Pre-dose, up to 1month
AUCinf of Aricept
Area under the concentration-time curve from time zero to infinity
Measured: Pre-dose, up to 1month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start1 Apr 2023
- Primary completion13 Nov 2025 (estimated)
- Study completion13 Nov 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inventage Lab., Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345509
- Sponsor's protocol ID
- IVL3003-001
- Status last verified
- Dec 2024
- First submitted
- 19 Apr 2022
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-Label, Exploratory, Sequential, Pharmacokinetic Single Ascending Dose Study of IVL3003 Versus Multiple Doses of Aricept (Donepezil) Tablets in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05345509
- Acronym / sponsor ID
- IVL3003-001
- Conditions
- Alzheimer Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Inventage Lab., Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 13 Nov 2025 (estimated)
- Study completion
- 13 Nov 2025 (estimated)
- First posted
- 26 Apr 2022 (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.
A Clinical Trial to Assess Pharmacokinetic Profiles and Safety of IVL3003
Detailed description
A Phase 1, Randomized, Open-Label, Exploratory, Sequential, Pharmacokinetic Single Ascending Dose Study of IVL3003 Versus Multiple Doses of Aricept (Donepezil) Tablets in Healthy Subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Aricept Tablet | Active comparator | Drug: Aricept TabletAricept Tablet, QD, PO |
| IVL3003 (A mg) | Experimental | Drug: IVL3003SC, Single Dose |
| IVL3003 (B mg) | Experimental | Drug: IVL3003SC, Single Dose |
| IVL3003 (C mg) | Experimental | Drug: IVL3003SC, Single Dose |
| IVL3003 (Dmg) | Experimental | Drug: IVL3003Intramuscular |
| IVL3003 (Emg) | Experimental | Drug: IVL3003Intramuscular |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy male or female, ≥18 and ≤55 years of age, non-smokers or occasional smokers (defined as smoking less than 10 cigarettes or nicotine equivalent per week, and willing to abstain from smoking during confinement at the study site).
- Body mass index (BMI) ≥18.0 and ≤32.0 kg/m2 and body weight ≥55.0 kg for males and ≥50.0 kg for females.
- Male subjects who are sexually active with a same-sex partner must be willing to use a condom until study exit.
- Male and female subjects who practice abstinence from sexual intercourse as a usual and preferred lifestyle.
- Willing to abstain from use of non-steroidal anti-inflammatory drugs (NSAIDs) including ibuprofen, naproxen, aspirin, meloxicam, etc. from screening until study exit.
Key exclusion criteria (17 listed)
- Any clinically significant abnormal finding at physical examination at screening.
- Clinically significant abnormal laboratory test results or positive serology test results for human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus at screening.
- Positive pregnancy test at screening or Day -1 or lactating female subject.
- Positive drug or alcohol screen at screening or Day -1.
- Any history of malignancy or neoplastic disease.
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 |
|---|---|---|
| Aricept TabletDonepezil Tablet once daily P.O | Drug | Aricept Tablet |
| IVL3003Donepezil Long-Acting Injection, once S.C Injection | Drug | IVL3003 (A mg), IVL3003 (B mg), IVL3003 (C mg) |
| IVL3003Donepezil Long-Acting Injection, once IM Injection | Drug | IVL3003 (Dmg), IVL3003 (Emg) |
Primary outcome
AUClast of IVL3003
Time frame: Pre-dose, up to 1month
Area under the concentration-time curve from time zero to last
AUCinf of IVL3003
Time frame: Pre-dose, up to 1month
Area under the concentration-time curve from time zero to infinity
AUClast of Aricept
Time frame: Pre-dose, up to 1month
Area under the concentration-time curve from time zero to last
AUCinf of Aricept
Time frame: Pre-dose, up to 1month
Area under the concentration-time curve from time zero to infinity
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Aricept Tablet and IVL3003 in people with Alzheimer Disease, run by Inventage Lab., Inc. at 1 site in Australia.
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 6 inclusion and 17 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: under way, not looking for participants, as of the sponsor's last update on 19 Dec 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 Australia. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
AUClast of IVL3003 (time frame: Pre-dose, up to 1month). The study lists 4 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 19 Dec 2024.