MedTrace Logo

Single Ascending Dose and Multiple Ascending Dose Study of AVR-48

NCT06847698 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-04-06

No results posted yet for this study

Summary

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.

Conditions

  • Safety Issues
  • Tolerability
  • Pharmacokinetics
  • Pharmacodynamics

Interventions

DRUG

AVR-48

Investigational drug reconstituted in normal saline will be administered via IV

DRUG

Placebo

Normal saline will be administered via IV

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • AyuVis Research, Inc.

    lead INDUSTRY

Principal Investigators

  • Suchismita Acharya, PhD · AyuVis Research, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2025-10-31
Completion
2025-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06847698 on ClinicalTrials.gov