Clinical trial · Interventional
Pharmacokinetic Study of a Single Dose of AVI-4126 (RESTEN-NG®) in Cerebral Spinal Fluid
Pharmacokinetic Study of AVI-4126 in Cerebral Spinal Fluid Among Healthy Adult Males Following Intravenous Administration
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Because AVI-4020 Injection was found to cross the blood-brain barrier, and because AVI-4126 (RESTEN-NG) has potential medical benefit to people with a variety of diseases, including cancers, this study is being performed to find out if AVI-4126 also crosses the blood-brain barrier. If it does, then additional investigations could be performed, such as in people with certain types of cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AVI-4126 Injection (RESTEN-NG®) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine if the study drug penetrates the blood brain barrier following a single intravenous dose, and if so, the associated CSF, plasma and urine pharmacokinetics.
Secondary outcomes (2)
- measure
- Safety
- measure
- Tolerability
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 64 Years
Show eligibility criteria text
Inclusion Criteria: * Adult males 18 years to 64 years of age; * Good general health (as evidenced by no chronic conditions, normal physical exam, vital signs within normal limits; laboratory evaluations within normal range) * Signed and dated written informed consent form; and * Willing to participate in all study activities and all requirements, including effective contraception (viz., a double-barrier method) during the 7-day study surveillance period. Exclusion Criteria: * Hematology, serum chemistry (exclusive of electrolytes), and urinalysis laboratory test values \>2 times upper limits of normal or anemia (hemoglobulin \<11 g/dL), leukopenia (total white blood count \<3,000/µL or total neutrophils \<1,500/ µL) or thrombocytopenia (platelets \<100,000/µL). Electrolytes and coagulation values exceeding normal ranges are to be excluded. * Body Mass Index (BMI) \>35. * Calculated creatinine clearance (by the Cockroft and Gault Formula) \<70 mL/min, based on age and gender. * Positive HIV-1 or HIV-2 serology. * Positive HCV serology and/or positive plasma HCV-RNA status. * Positive HBsAg or HBcAb status. * Solid or hematopoetic organ transplant recipient. * Active illness or recent illness within 30 days of the first dose of study drug. * History of any of the following: brain injury, neoplasm, chronic or migraine headaches, cancer, meningitis or hydrocephalus. * Usage of any prescribed, over-the-counter or illicit drug(s) within 30 days of study drug administration. Use of herbal remedies and/or supplements at the discretion of the Investigator. * Unwilling to practice effective contraception during the study period. * Participation in any clinical interventional trial within the previous 6 months. * Positive drug urine screen.
References
Publications (0)
Data not yet available