A Clinical Trial to Assess Pharmacokinetic Profiles, Safety and Tolerability of IVL3004 and IVL4002 in Healthy Male Subjects.

Last updated: September 9, 2025
Sponsor: Inventage Lab., Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Memory Loss

Opioid Use Disorder

Multiple Sclerosis

Treatment

IVL4002

Vivitrol Injectable Product

IVL3004

Clinical Study ID

NCT05620940
IVL3004-001
  • Ages 18-55
  • Male
  • Accepts Healthy Volunteers

Study Summary

A Clinical Trial to Assess Pharmacokinetic Profiles, Safety and Tolerability of IVL3004 and IVL4002 in Healthy Male Subjects.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Healthy adult male, ≥18 and ≤55 years of age, non-smokers or occasional smokers (defined as smoking less than 10 cigarettes or nicotine equivalent per week, andwilling to abstain from smoking during confinement at the clinical site).

  2. BMI ≥18.0 and ≤32.0 kg/m2 and body weight ≥55.0 kg.

  3. Healthy as defined by:

  4. The absence of clinically significant illness, infection, or medical/surgicalprocedure within 4 weeks prior to dosing or planned inpatient surgery (including dental surgery) or hospitalization during the study period.

  5. The absence of clinically significant history of neurological, endocrine,cardiovascular, respiratory, hematological, immunological (includingautoimmune), psychiatric, gastrointestinal, renal, hepatic, and metabolicdisease.

  6. Subjects who are not vasectomized for at least 3 months prior to dosing, and who aresexually active with a female partner of childbearing potential must be willing touse one of the following acceptable contraceptive methods from dosing and for 90days after dosing: a. Simultaneous use of a male condom and, for the female partner, hormonalcontraceptives used for at least 4 weeks or intrauterine device placed for at least 4 weeks prior to dosing.

  7. Subjects who have had a vasectomy must be willing to use a condom until study exit.

  8. Subjects who practice abstinence from sexual intercourse as a usual and preferredlifestyle.

  9. Subjects must be willing not to donate sperm for 90 days after dosing.

  10. Willing to undergo SC abdominal injection or IM ventral gluteal injection to allowfor investigational drug administration.

  11. Willing and able to provide written informed consent after the nature of the studyhas been explained and prior to the commencement of any protocol- specific studyprocedures.

Exclusion

Exclusion Criteria:

  1. Any clinically significant abnormal finding at physical examination at screening orDay -1.

  2. Clinically significant abnormal laboratory test results at screening or Day -1, orpositive serology test results for human immunodeficiency virus (HIV), hepatitis Bor hepatitis C virus at screening.

  3. Is prone to skin rashes, irritation, or has a skin condition such as recurrenteczema that is likely to impact the injection site area or demonstrates any abnormalskin tissue in the proposed injection area, as determined by the Investigator.

  4. Any history of malignancy or neoplastic disease.

  5. History of significant allergic reactions (e.g., drug reaction, anaphylacticreaction, hypersensitivity, angioedema) to any drug, or to any excipient present inthe formulations.

  6. ALT, AST, or total bilirubin >1.5x upper limit of normal (ULN) at screening or Day -1.

  7. 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.

  8. Clinically significant ECG abnormalities (QTc >450 ms or PR interval >220 ms) orvital sign abnormalities (systolic blood pressure <90 or >140 mmHg, diastolic bloodpressure <40 or >90 mmHg, or heart rate <40 or >100 bpm) at screening or Day -1.

  9. History of alcohol abuse within 1 year prior to screening or regular use of alcoholwithin 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%), or positivealcohol test at screening or Day -1.

  10. History of drug abuse within 1 year prior to screening or positive test for drugs ofabuse (e.g., phencyclidine, opiates, benzodiazepines, barbiturates, amphetamines,methamphetamines, cocaine, and tetrahydrocannabinol) at screening or Day -1.

  11. Presence of any underlying physical or psychological (e.g., depression) medicalcondition that, in the opinion of the Investigator, would make it unlikely that theparticipant will comply with the protocol or complete the study per protocol. Milddepression and anxiety that has been resolved at least 6 months prior to screeningis accepted.

  12. Use of medications for the timeframes specified below, with the exception ofhormonal contraceptives and medications exempted by the Investigator on acase-by-case basis because they are judged unlikely to affect the PK profile of thestudy drug or subject safety:

  13. Depot injection or implant within 3 months prior to dosing;

  14. Strong CYP inhibitors or inducers within 30 days prior to dosing;

  15. Prescription medications within 14 days prior to dosing;

  16. Any vaccine, including COVID-19 vaccine, within 7 days prior to dosing;

  17. OTC medications (including topical and nasal formulations with activepharmaceutical ingredients) within 7 days prior to dosing, except foroccasional use of acetaminophen/paracetamol (up to 2 g/day);

  18. Natural health products (including herbal remedies, homeopathic and traditionalmedicines, probiotics, food supplements such as vitamins, minerals, aminoacids, essential fatty acids, and protein supplements used in sports) within 7days prior to dosing;

  19. Anesthetic agents within 24 hours prior to dosing.

  20. Anticoagulant medications from 15 days prior to dosing to 6 weeks post- dose.

  21. Participation in a clinical research study involving the administration of aninvestigational or marketed drug or device within 30 days prior to dosing,administration of a biological product in the context of a clinical research studywithin 90 days prior to dosing, or concomitant participation in an investigationalstudy involving no drug or device administration.

  22. Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL ormore of whole blood within 30 days prior to dosing.

  23. Any reason which, in the opinion of the Investigator, would prevent the subject fromparticipating in the study.

Study Design

Total Participants: 40
Treatment Group(s): 3
Primary Treatment: IVL4002
Phase: 1
Study Start date:
September 11, 2024
Estimated Completion Date:
December 30, 2025

Study Description

A Phase 1, Open-Label, Exploratory, Fixed-Sequence, Pharmacokinetic Single Acending Dose Study of IVL3004 Versus Vivitrol® (Naltrexone) Long-Acting Injectable(LAI) and IVL4002 in Healthy Subjects

Connect with a study center

  • Nucleus Network

    Herston, Queensland 4006
    Australia

    Site Not Available

  • Nucleus Network

    Herston 6931014, Queensland 2152274 4006
    Australia

    Active - Recruiting

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