Actively Recruiting
Phase 1 Study Comparing IVL3004 and IVL4002 to Vivitrol4 Naltrexone Long-Acting Injection in Healthy Adult Males
Led by Inventage Lab., Inc. · Updated on 2025-09-15
40
Participants Needed
1
Research Sites
N/A
Total Duration
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.
Research Team
H
HyeRyeon Kim
H
Heesun Kim
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