Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
Drug Metabolism: Phase I Reactions01:17

Drug Metabolism: Phase I Reactions

A phase I reaction is a biochemical process that introduces a functionally reactive polar group to a substance. This transformation predominantly occurs in the liver, facilitated by the cytochrome P450 system of hemoproteins situated in the lipophilic endoplasmic reticulum of cells. The metabolite generated through this process can have varying polarities. If it is sufficiently polar, it can be easily excreted in the urine due to its water compatibility. However, if the metabolite is nonpolar,...
Preclinical Development: Overview01:28

Preclinical Development: Overview

Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
Drug Administration and Therapy Phases: Overview01:26

Drug Administration and Therapy Phases: Overview

Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
Bioavailability Study Design: Single Versus Multiple Dose Studies01:11

Bioavailability Study Design: Single Versus Multiple Dose Studies

Bioavailability studies are essential for understanding how a drug is absorbed, distributed, metabolized, and excreted in the body. These studies assess the extent and rate at which the active pharmaceutical agent becomes available at the site of action. The design of bioavailability studies can involve single-dose or multiple-dose regimens, each with distinct advantages and limitations.Single-dose studies are the preferred approach due to their simplicity and reduced drug exposure for...
Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

High-speed particle analysis using forward and backward two-dimensional angular optical scattering.

Optics letters·2026
Same author

Early vs. late definitive fixation of pelvic ring fractures in resuscitated polytraumatized patients: a systematic review and meta-analysis.

Archives of orthopaedic and trauma surgery·2025
Same author

Validating an open access and low-cost 3D-printed dermatoscope for enhanced accessibility into dermoscopy.

Clinical and experimental dermatology·2025
Same author

Subcutaneous zilucoplan: Evaluation of reproductive toxicology.

Reproductive toxicology (Elmsford, N.Y.)·2025
Same author

Clinical presentation and diagnosis of adult-onset leukoencephalopathy with axonal spheroids and pigmented glia: a literature analysis of case studies.

Frontiers in neurology·2024
Same author

A preoperative nomogram incorporating CT to predict the probability of ovarian clear cell carcinoma.

Gynecologic oncology·2023

Related Experiment Video

Updated: Jul 10, 2026

Orthotopic Xenografting of Human Luciferase-Tagged Malignant Peripheral Nerve Sheath Tumor Cells for in vivo Testing of Candidate Therapeutic Agents
07:10

Orthotopic Xenografting of Human Luciferase-Tagged Malignant Peripheral Nerve Sheath Tumor Cells for in vivo Testing of Candidate Therapeutic Agents

Published on: March 7, 2011

18.6K

Phase 1, First-In-Human, Single-/Multiple-Ascending Dose Study of Iluzanebart in Healthy Volunteers.

Andreas Meier1, Spyros Papapetropoulos1, Andrew Marsh1

  • 1Formerly Vigil Neuroscience, Inc., Watertown, Massachusetts, USA.

Annals of Clinical and Translational Neurology
|April 1, 2025
PubMed
Summary

Iluzanebart, a TREM2 agonist, showed favorable safety and tolerability in healthy volunteers. This antibody demonstrated good pharmacokinetics and central nervous system exposure, supporting its development for neurological conditions.

Keywords:
CSF‐1 receptorTREM2adult‐onset leukoencephalopathy with axonal spheroids and pigmented gliailuzanebartmicroglia

More Related Videos

Evaluation of Zika Virus-specific T-cell Responses in Immunoprivileged Organs of Infected Ifnar1-/- Mice
10:01

Evaluation of Zika Virus-specific T-cell Responses in Immunoprivileged Organs of Infected Ifnar1-/- Mice

Published on: October 17, 2018

7.9K
A Human Peripheral Blood Mononuclear Cell PBMC Engrafted Humanized Xenograft Model for Translational Immuno-oncology I-O Research
08:17

A Human Peripheral Blood Mononuclear Cell PBMC Engrafted Humanized Xenograft Model for Translational Immuno-oncology I-O Research

Published on: August 15, 2019

14.2K

Related Experiment Videos

Last Updated: Jul 10, 2026

Orthotopic Xenografting of Human Luciferase-Tagged Malignant Peripheral Nerve Sheath Tumor Cells for in vivo Testing of Candidate Therapeutic Agents
07:10

Orthotopic Xenografting of Human Luciferase-Tagged Malignant Peripheral Nerve Sheath Tumor Cells for in vivo Testing of Candidate Therapeutic Agents

Published on: March 7, 2011

18.6K
Evaluation of Zika Virus-specific T-cell Responses in Immunoprivileged Organs of Infected Ifnar1-/- Mice
10:01

Evaluation of Zika Virus-specific T-cell Responses in Immunoprivileged Organs of Infected Ifnar1-/- Mice

Published on: October 17, 2018

7.9K
A Human Peripheral Blood Mononuclear Cell PBMC Engrafted Humanized Xenograft Model for Translational Immuno-oncology I-O Research
08:17

A Human Peripheral Blood Mononuclear Cell PBMC Engrafted Humanized Xenograft Model for Translational Immuno-oncology I-O Research

Published on: August 15, 2019

14.2K

Area of Science:

  • Neuroscience
  • Immunology
  • Pharmacology

Background:

  • Triggering receptor expressed on myeloid cells 2 (TREM2) plays a crucial role in microglial function.
  • Dysregulation of TREM2 is implicated in various neurological disorders, including adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (LAB22).
  • Iluzanebart is a novel monoclonal antibody designed to activate TREM2.

Purpose of the Study:

  • To assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of iluzanebart.
  • To evaluate iluzanebart's effects after single-ascending dose (SAD) and multiple-ascending dose (MAD) administration.
  • To explore iluzanebart's impact on cerebrospinal fluid (CSF) biomarkers related to TREM2 activity.

Main Methods:

  • A Phase 1 study involving 136 healthy adult volunteers.
  • Administration of placebo or iluzanebart (1-60 mg/kg) via intravenous infusion.
  • Serial assessments of safety (adverse events, vital signs, ECGs, labs) and PK.
  • Exploratory CSF collection for PD biomarker analysis in open-label cohorts.

Main Results:

  • Iluzanebart was safe and well-tolerated up to 60 mg/kg in SAD and MAD cohorts.
  • The most common adverse event was mild pruritus; no serious adverse events were reported.
  • Demonstrated dose-related serum exposure, a 29-day half-life supporting monthly dosing, and central nervous system (CNS) penetration (≈0.15% CSF-to-serum ratio).
  • Observed durable, dose-dependent target engagement with reduced soluble TREM2 and increased soluble CSF1R and osteopontin in CSF, indicating modulation of microglial activity.

Conclusions:

  • Iluzanebart exhibits a favorable safety and tolerability profile.
  • The drug possesses suitable pharmacokinetic properties for clinical use, including CNS exposure.
  • Pharmacodynamic effects suggest iluzanebart modulates TREM2-related pathways, supporting its further development for neurological diseases.