A Study to Learn How Safe EV25 is, the Amount of EV25 in the Body Over a Period of Time, and the Effects of EV25 on the Body in Adult Healthy People Taking Single Doses via the Nose in the Presence or Absence of Influenza Virus

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Eradivir Inc.

Participant type

Healthy volunteers

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02]

Trial duration

12 Nov 2024 → 13 May 2025

Decision date (initial)

2024-11-07

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Others, Safety

Part I: To assess the safety and tolerability of a single dose of EV25 intranasal administration in healthy participants. To determine the single-dose PK profile of EV25 intranasal administration in healthy participants.
Part II: To assess the safety and tolerability of a single dose of EV25 intranasal administration in healthy participants exposed to influenza H3N2. To assess the effect of single doses of EV25 on viral AUC compared to placebo in healthy participants exposed to influenza H3N2 with positive predose values.

Secondary objectives 3

1. Part II: To determine the single-dose PK profile of EV25 intranasal administration in healthy participants exposed to influenza H3N2.
2. Part II: To assess the effect of single doses of EV25 viral shedding compared to placebo in healthy participants exposed to influenza H3N2.
3. Part II: To assess the effect of single doses of EV25 on measurements of disease severity compared to placebo in healthy participants exposed to influenza H3N2.

Conditions and MedDRA coding

Virus Influenza

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Informed Consent Form (ICF) signed voluntarily before any study-related procedure is performed, indicating that the participant understands the purpose of, and procedures required for the study and is willing to participate in the study.
2. Female participants are eligible to participate if they are not pregnant or breastfeeding, nor planning to become pregnant or breastfeeding during the study (from screening to 30 days after administration of study intervention).
3. Female participants must agree not to donate eggs from screening to 30 days after administration of study intervention.

Exclusion criteria 3

1. History of autoimmune disease or known impaired immune response.
2. Participant has: a. A history of alcohol abuse (consume, on average, more than 14 units of alcohol for male participants or 7 units of alcohol for female participants per week) within the 2 years prior to randomization, and unwillingness to be totally abstinent during confinement. b. A positive alcohol breath test at screening or upon check-in at the clinical site on Day -1 in Part 1 (SAD) or Day -2 in Part 2 (Influenza Challenge).
3. Active smoker and/or has used nicotine or nicotine-containing products (including e‑cigarettes or the equivalent of e-cigarettes) within the 6 months prior to randomization. Urine cotinine test must be negative at screening and upon check-in at the clinical site on Day -1 in Part 1 (SAD) or Day -2 in Part 2 (Influenza Challenge).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Part I: AEs, laboratory safety assessments,12-lead ECG findings, vital signs, physical examination findings, and intranasal administration site examination findings.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Eradivir Inc.

Sponsor organisation

Eradivir Inc.

Address

1209 North Orange Street

City

Wilmington

Postcode

19801-1120

Country

United States

Scientific contact point

Organisation

Eradivir Inc.

Contact name

-

Public contact point

Organisation

Eradivir Inc.

Contact name

-

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 85 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications