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RECRUITING
NCT07222670
PHASE2

A Study Assessing Safety, Tolerability, and Efficacy of INNA-051 in Preventing Respiratory Illness Due to Viral Infections in Healthy Adults 18 to 45 Years of Age

Sponsor: ENA Respiratory Pty Ltd

View on ClinicalTrials.gov

Summary

Acute upper and lower respiratory infections are a major public health problem and a leading cause of morbidity and mortality worldwide. The purpose of this trial is to assess the safety of the investigational agent INNA-051, given intranasally, and its potential effectiveness in reducing the occurrence, severity, and/or the duration of illness resulting from respiratory virus infections. The trial will enroll generally healthy adults (age 18 - 45 years) who are at risk for exposure to viral respiratory infection, for example, due to living conditions or occupation. Participants will be treated with INNA-051 or placebo once weekly for 4 weeks (Part A) or 12 weeks (Part B) during the respiratory virus season.

Official title: A Randomized, Double-Blind, Two-Part, Placebo-Controlled, Multicenter, Phase 2a Study to Evaluate Safety, Tolerability, and Efficacy of INNA-051 as Prophylaxis for Respiratory Tract Illness in Healthy Adults 18 to 45 Years of Age Who Are at Risk for Viral Respiratory Infections

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

1100

Start Date

2025-12-04

Completion Date

2027-02-09

Last Updated

2026-02-11

Healthy Volunteers

Yes

Interventions

DRUG

INNA-051

powder nasal spray.

OTHER

Placebo

powder nasal spray.

Locations (5)

Center for Vaccine Development and Global Health (CVD)

Baltimore, Maryland, United States

Naval Medical Research Command (NMRC)

Bethesda, Maryland, United States

Accellacare of Raleigh

Raleigh, North Carolina, United States

Accellacare of Piedmont HealthCare

Statesville, North Carolina, United States

Accellacare - Wilmington

Wilmington, North Carolina, United States