Actively Recruiting
A Phase 1, Open-Label, Exploratory, Fixed-Sequence Single Ascending Dose Study Comparing IVL3004 and IVL4002 to Vivitrol® (Naltrexone) Long-Acting Injectable in Healthy Male Subjects
Led by Inventage Lab., Inc. · Updated on 2025-09-15
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the pharmacokinetic profiles, safety, and tolerability of two investigational drugs, IVL3004 and IVL4002, compared to Vivitrol (Naltrexone) Long-Acting Injectable. This phase 1, open-label study involves healthy adult male volunteers aged 18 to 55 years. The purpose is to explore how these drugs behave in the body when given as single ascending doses and to assess any safety concerns. The study consists of multiple groups receiving single doses of either Vivitrol via intramuscular injection or varying doses of IVL3004 and IVL4002 administered either intramuscularly or subcutaneously. Participants will receive these injections in a fixed sequence to compare the pharmacokinetic properties of each drug. Participants will undergo assessments from before dosing up to day 57, including measurements of drug concentration over time (AUC and Cmax). They will be monitored for safety and tolerability through physical exams, laboratory tests, and observation for adverse effects. The total study participation spans several weeks with follow-up visits to collect data on how the drugs are processed in the body and any side effects experienced.
CONDITIONS
Brief Title
A Clinical Trial to Assess Pharmacokinetic Profiles, Safety and Tolerability of IVL3004 and IVL4002 in Healthy Male Subjects.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adult males aged 18 to 55 years
- Non-smokers or occasional smokers (less than 10 cigarettes or nicotine products per week) willing to abstain during confinement
- Body mass index between 18.0 and 32.0 kg/m2 and body weight at least 55.0 kg
- No clinically significant illness, infection, or surgery within 4 weeks before dosing
- No significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, or metabolic diseases
- Not vasectomized for at least 3 months prior or willing to use condoms and female partner contraception for 90 days after dosing
- Willing to undergo subcutaneous abdominal or intramuscular ventral gluteal injection
- Able and willing to provide written informed consent
You will not qualify if you...
- Any significant abnormal physical exam or lab test at screening or Day -1
- Positive tests for HIV, hepatitis B, or hepatitis C
- Skin conditions affecting injection site or prone to rashes
- History of cancer or neoplastic disease
- Significant allergic reactions to drugs or excipients
- Liver enzymes or bilirubin above 1.5 times normal
- Reduced kidney function (eGFR below 60 mL/min/1.73m2)
- Abnormal ECG or vital signs beyond specified limits
- Recent alcohol or drug abuse or positive tests
- Underlying physical or psychological conditions likely to interfere with study compliance
- Use of certain medications, vaccines, herbal or natural products within specified timeframes before dosing
- Participation in other clinical studies within 30 to 90 days prior
- Recent blood or plasma donation
- Any other reason deemed by the investigator to prevent participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 57 days
Participants receive a single dose injection of one of the study drugs: Vivitrol (Naltrexone), IVL3004, or IVL4002, administered either intramuscularly or subcutaneously.
Multiple visits for pharmacokinetic sampling and safety assessments up to Day 57
Trial Site Locations
Total: 1 location
1
Nucleus Network
Herston, Queensland, Australia, 4006
Actively Recruiting
Research Team
H
HyeRyeon Kim
H
Heesun Kim
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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