Active not recruitingPhase 1 / PHASE2

A Clinical Trial to Access Pharmacokinetic Profiles and Safety of IVL3003.

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

Lead sponsor

Inventage Lab., Inc.

Assets

Donepezil / IVL3003

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease

Key I/E criterion

•Age 18-55

Primary endpoints

•AUClast of IVL3003•AUCinf of IVL3003•AUClast of Aricept

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDIVL3003-001

NCT IDNCT05345509

Timeline

Milestones

Study first posted2022-04-26actual

Study start2023-04-01actual

Last update posted2024-12-19actual

Primary completion2025-11-13estimated

Study completion2025-11-13estimated

Assets

Drug assets

Donepezil IVL3003

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•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

Exclusion criteria

•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.

•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.

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Other (unclassified)

4 endpoints

Primary/protocol endpoint/low confidence

AUClast of IVL3003

Time frame:Pre-dose, up to 1month

concentration, descriptive

Primary/protocol endpoint/low confidence

AUCinf of IVL3003

Time frame:Pre-dose, up to 1month

concentration, descriptive

Primary/protocol endpoint/low confidence

AUClast of Aricept

Time frame:Pre-dose, up to 1month

concentration, descriptive

Primary/protocol endpoint/low confidence

AUCinf of Aricept

Time frame:Pre-dose, up to 1month

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.