Actively Recruiting
A Clinical Trial to Assess Pharmacokinetic Profiles, Safety and Tolerability of IVL3004 and IVL4002 in Healthy Male Subjects.
Led by Inventage Lab., Inc. · Updated on 2025-09-15
40
Participants Needed
1
Research Sites
67 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Clinical Trial to Assess Pharmacokinetic Profiles, Safety and Tolerability of IVL3004 and IVL4002 in Healthy Male Subjects.
CONDITIONS
Official 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 equivalent per week) willing to abstain from smoking 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 disease
- Not vasectomized for at least 3 months prior to dosing, or willing to use acceptable contraception if sexually active with female partner of childbearing potential
- Willing to use condom if vasectomized until study exit
- Willing to abstain from sperm donation for 90 days after dosing
- Willing to receive subcutaneous abdominal or intramuscular ventral gluteal injections
- Able and willing to provide written informed consent
You will not qualify if you...
- Any clinically significant abnormal physical exam findings at screening or Day -1
- Abnormal laboratory tests or positive HIV, hepatitis B or C serology at screening or Day -1
- Skin conditions affecting injection sites, such as recurrent eczema or abnormal skin tissue
- History of malignancy or neoplastic disease
- History of significant allergic reactions to drugs or excipients in the formulations
- Elevated liver enzymes (ALT, AST) or bilirubin greater than 1.5 times upper limit of normal
- Reduced kidney function (eGFR less than 60 mL/min/1.73m2)
- Abnormal ECG or vital signs outside specified ranges at screening or Day -1
- History of alcohol abuse within 1 year or regular alcohol use exceeding 14 units per week within 6 months
- History of drug abuse within 1 year or positive drug abuse tests at screening or Day -1
- Presence of medical or psychological conditions that might prevent compliance or study completion
- Use of certain medications or vaccines within specified timeframes before dosing
- Participation in other clinical research with investigational drugs or biological products within specified timeframes
- Recent plasma donation or significant blood loss
- Any other reasons judged by the Investigator to prevent study participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Nucleus Network
Herston, Queensland, Australia, 4006
Actively Recruiting
Research Team
H
HyeRyeon Kim
CONTACT
H
Heesun Kim
CONTACT
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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