Study to Learn How Safe EV25 is and the Amount of EV25 in the Body Over a Period of Time, When Given as a Single Dose to Adult Healthy People [CCI]

2026-525176-26-00 Protocol EV-FLU-CL-BR01 Human pharmacology (Phase I) - Other Ongoing, recruiting

Start 28 May 2026 · Status Ongoing, recruiting · 1 EU/EEA countries · 1 sites · Protocol EV-FLU-CL-BR01

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other
Status Ongoing, recruiting
Participants planned 16
Countries 1
Sites 1

Influenza

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
28 May 2026 → ongoing
Decision date (initial)
2026-04-30
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Influenza

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

CountryMS statusPlanned subjectsSites
Belgium Ongoing, recruiting 16 1
Rest of world 0

Investigational sites

Belgium

1 site · Ongoing, recruiting
SGS Belgium
SGS - Clinical Research, Drie Eikenstraat 655, 2650, Edegem

Country notifications

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

Country Trial startTrial end Recruitment startRecruitment end Early termination
Belgium 2026-05-28 2026-05-28

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2026-03-20 Belgium Acceptable with conditions
2026-04-30
2026-04-30
2 SUBSTANTIAL MODIFICATION SM-1 2026-05-05 Belgium Acceptable
2026-05-19
2026-05-19