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

48 Participants Needed

Trial Summary

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.

What is the purpose of this trial?

This is a Phase 1 (healthy adult volunteers), 2-part, double-blind, randomized, placebo controlled trial to evaluate the safety and pharmacokinetic (PK) profiles of escalating single doses of AVR-48 versus placebo (SAD) and escalating multiple doses of AVR-48 versus placebo (MAD). SAD will be initiated first and include a sentinel dosing design. MAD will not utilize a sentinel design unless the safety monitoring committee requests the addition of sentinels. The MAD will be initiated once the lowest doses from SAD are deemed safe.

Research Team

Suchismita Acharya, PhD

Principal Investigator

AyuVis Research, Inc.

Eligibility Criteria

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 haven't smoked or used nicotine products for at least 3 months.

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

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

Treatment Details

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.

Participant Groups

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+