AVR-48 for Safety Evaluation

Overseen By Jia W Chang, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: AyuVis Research, Inc.

Must not be taking: Prescription drugs

Disqualifiers: Alcoholism, Drug abuse, HIV, others

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety of a new drug called AVR-48, designed to modulate immune responses. As a Phase 1 trial, it represents the first step in testing this drug's safety in healthy individuals. The trial will compare different doses of AVR-48 to a placebo (a substance with no active medicine) to observe how the body processes it. Ideal participants are healthy adults who do not smoke or use nicotine products. Participants will be among the first to receive this new treatment, contributing to understanding how it works in people.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any prescription or non-prescription medications, herbal remedies, or vitamin supplements starting 14 days before the first dose and throughout the study. However, acetaminophen (up to 2 grams per day) and hormone replacement therapy are allowed.

Is there any evidence suggesting that AVR-48 is likely to be safe for humans?

Research has shown that AVR-48, a new drug, has been tested in animals like mice. These studies found it can help with lung problems without causing major side effects. However, this trial marks the first time AVR-48 is tested in humans. As a Phase 1 study, the main goal is to determine its safety for healthy individuals. Researchers closely monitor for any side effects, administering the drug in small, gradually increasing doses to assess tolerance. This method helps ensure safety before progressing to larger studies. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

AVR-48 stands out because it targets the TLR4 receptor and modulates macrophage activity, offering a fresh mechanism of action compared to existing treatments. Unlike standard therapies for conditions involving immune response, which often focus on symptom relief, AVR-48 aims to directly modulate the immune system at a cellular level. This novel approach could lead to more precise and effective management of immune-related conditions, sparking excitement among researchers for its potential to improve outcomes.

What evidence suggests that AVR-48 might be an effective treatment?

Research has shown that AVR-48, which participants in this trial may receive, can help reduce lung damage and improve lung function. In animal studies, AVR-48 improved lung health and eased breathing problems in preterm lambs and mice exposed to harmful conditions. It also helped prevent serious lung diseases like bronchopulmonary dysplasia in newborn mice. These findings suggest that AVR-48 could be promising for treating lung issues by affecting TLR4, a protein involved in the immune response. Although more research is needed in humans, these early results are encouraging. ^{1 3 4 5 6}

Who Is on the Research Team?

Suchismita Acharya, PhD

Principal Investigator

AyuVis Research, Inc.

Are You a Good Fit for This Trial?

This trial is for healthy adult volunteers interested in testing a new medication, AVR-48. Participants must meet certain health standards but specific inclusion and exclusion criteria are not detailed here.

Inclusion Criteria

Provision of signed and dated informed consent form (ICF)

Stated willingness to comply with all study procedures and availability for the duration of the study

I am a healthy adult between 18 and 55 years old.

Exclusion Criteria

History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study

Positive result at screening for tuberculosis (i.e., positive result for QuantiFERON TB-Gold)

I have a significant health or mental condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose (SAD)

Participants receive a single IV dose of AVR-48 or placebo in a sentinel dosing design

1 week

Multiple visits for dosing and monitoring

Multiple Ascending Dose (MAD)

Participants receive multiple IV doses of AVR-48 or placebo over 7 days

1 week

Daily visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 follow-up visit 7 days after last dose

What Are the Treatments Tested in This Trial?

Interventions

• AVR-48

Trial Overview AVR-48's safety and how it moves through the body (pharmacokinetics) are being tested against a placebo. The study has two parts: one with single escalating doses (SAD) and another with multiple ascending doses (MAD), both compared to a placebo.

How Is the Trial Designed?

Group I: Drug: AVR-48 Experimental Treatment 1 Intervention

AVR-48 is a small molecule with TLR4 modulating activity and macrophage modulator

Group II: Drug: Placebo Placebo Group 1 Intervention

0.9% saline

Who Is Running the Clinical Trial?

AyuVis Research, Inc.

Lead Sponsor

Trials

1

Recruited

50+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40855290/

Pulmonary and neurobehavioral efficacies of AVR-48, a TLR4 ... AVR-48 reduced respiratory severity, improved lung compliance, and improved neurodevelopmental outcomes in preterm lambs, and is a promising ...

2. respiratory-research.biomedcentral.com respiratory-research.biomedcentral.com/articles/10.1186/s12931-025-03337-z

Pulmonary and neurobehavioral efficacies of AVR-48, a TLR4 ... Treatment with AVR-48 via intraperitoneal injection effectively prevented hyperoxia-induced pathology in a newborn mouse model of ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06847698

Study Details | NCT06847698 | Single Ascending Dose ... This Phase 1 study evaluates the safety and pharmacokinetics of AVR-48 in two parts: single ascending dose (SAD) and multiple ascending dose (MAD) versus ...

4. mdpi.com mdpi.com/2673-5601/2/4/40

Chitin Derived Small Molecule AVR-48 Reprograms the ... AVR-48 is a structural derivative of chitin previously shown by our laboratory to significantly decrease lung injury parameters in LPS, hyperoxia and sepsis- ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8395179/

Chitin-Derived AVR-48 Prevents Experimental ... Chitin-derived AVR-48 prevents experimental bronchopulmonary dysplasia (BPD) and BPD-associated pulmonary hypertension in newborn mice.

6. withpower.com withpower.com/trial/phase-1-pharmacodynamics-5-2025-5a9df

AVR-48 for Safety Evaluation · Info for Participants This is a Phase 1 (healthy adult volunteers), 2-part, double-blind, randomized, placebo controlled trial to evaluate the safety and pharmacokinetic (PK) ...