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

Conditions

• Viral Respiratory Illnesses
• Viral Respiratory Infection

Eligibility Criteria

Sex

ALL

Age

18 Years - 45 Years

Healthy Volunteers

Accepted

Interventions

• INNA-051 — DRUG
  powder nasal spray.
• Placebo — OTHER
  powder nasal spray.

Study Details

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.

Key Dates

Start date

Dec 4, 2025

Status verified

Feb 2026

Primary completion

Feb 9, 2027

Completion

Feb 9, 2027

Study Design

Enrollment

1,100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: INNA-051
• Placebo Comparator: Placebo

Primary Outcome Measure

Part A - Number of Participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to 8 weeks ]

Central Contacts

• ENA Respiratory
  [email protected]

Locations (5)

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