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Not yet recruiting Phase 1 Interventional Accepts healthy volunteers

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

ClinicalTrials.gov ID: NCT06847698

Public ClinicalTrials.gov record NCT06847698. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 4, 2026, 1:37 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Phase 1, Double-Blinded, Placebo-Controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Safety and Pharmacokinetics Trial of AVR-48

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06847698
Recruitment status
Not yet recruiting
Study type
Interventional
Phase
Phase 1
Lead sponsor
AyuVis Research, Inc.
Industry
Enrollment
48 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 55 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 31, 2025
Primary completion
Sep 30, 2025
Completion
Oct 31, 2025
Last update posted
Apr 5, 2025

2025

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
PPD Austin Texas 78744

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06847698, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 5, 2025 · Synced Sep 4, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06847698 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →