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

NCT05345509 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: IVL3003-001
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

A Clinical Trial to Assess Pharmacokinetic Profiles and Safety of IVL3003

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (4)

• AUClast of IVL3003

  Area under the concentration-time curve from time zero to last

  Pre-dose, up to 1month

• AUCinf of IVL3003

  Area under the concentration-time curve from time zero to infinity

  Pre-dose, up to 1month

• AUClast of Aricept

  Area under the concentration-time curve from time zero to last

  Pre-dose, up to 1month

• AUCinf of Aricept

  Area under the concentration-time curve from time zero to infinity

  Pre-dose, up to 1month

Study Arms (6)

Aricept Tablet

ACTIVE COMPARATOR

Aricept Tablet, QD, PO

Drug: Aricept Tablet

IVL3003 (A mg)

EXPERIMENTAL

SC, Single Dose

Drug: IVL3003

IVL3003 (B mg)

EXPERIMENTAL

SC, Single Dose

Drug: IVL3003

IVL3003 (C mg)

EXPERIMENTAL

SC, Single Dose

Drug: IVL3003

IVL3003 (Dmg)

EXPERIMENTAL

Intramuscular

Drug: IVL3003

IVL3003 (Emg)

EXPERIMENTAL

Intramuscular

Drug: IVL3003

Interventions

Aricept Tablet DRUG

Donepezil Tablet once daily P.O

Aricept Tablet

IVL3003 DRUG

Donepezil Long-Acting Injection, once S.C Injection

IVL3003 (A mg); IVL3003 (B mg); IVL3003 (C mg)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inventage Lab., Inc.: lead

Study Sites (1)

Nucleus Network

Melbourne, Australia

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Donepezil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Design

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

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: April 26, 2022
• Study Start: April 1, 2023
• Primary Completion: November 13, 2025
• Study Completion: November 13, 2025
• Last Updated: December 19, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)