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

Part of paid clinical trials in Austin, Texas.

Sponsor
AyuVis Research, Inc.
Study ID
NCT06847698
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Pharmacodynamics
  • Pharmacokinetics
  • Safety Issues
  • Tolerability

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • AVR-48 — DRUG
    Investigational drug reconstituted in normal saline will be administered via IV
  • Placebo — DRUG
    Normal saline will be administered via IV

Study Details

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.

Key Dates

Start date
Jun 30, 2025
Status verified
Apr 2025
Primary completion
Oct 31, 2025
Completion
Nov 30, 2025

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Drug: AVR-48
    AVR-48 is a small molecule with TLR4 modulating activity and macrophage modulator
  • Placebo Comparator: Drug: Placebo
    0.9% saline

Primary Outcome Measure

Number of participants who experience Adverse Events (AEs), Serious Adverse Events [ Time Frame: Up to 16 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
PPDAustinTexas78744
Study Principal Investigator
877-362-2608

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By research site
PPD· Austin, TX

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