A first-in-human, open-label, dose finding study to evaluate the safety, tolerability and pharmacokinetics of EGL-003 in healthy volunteers followed by adults with autoimmune disease.

Start 27 Oct 2025 · Status Authorised, recruiting · 3 EU/EEA countries · 12 sites · Protocol EGL-311

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - First administration to humans

Status Authorised, recruiting

Participants planned 58

Countries 3

Sites 12

Atopic dermatitis

Key facts

Sponsor: Egle Therapeutics
Participant type: Patients, Healthy volunteers
Age range: 18-64 years
Gender: Male and Female
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trial duration: 27 Oct 2025 → ongoing
Decision date (initial): 2025-10-06
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Atopic dermatitis

Version	Level	Code	Term	System organ class
21.1	LLT	10003639	Atopic dermatitis	10040785

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Egle Therapeutics

Sponsor organisation: Egle Therapeutics
Address: 5 Rue Gardenat Lapostol
City: Suresnes
Postcode: 92150
Country: France

Scientific contact point

Organisation: Egle Therapeutics
Contact name: Kenji Hashimoto

Public contact point

Organisation: Egle Therapeutics
Contact name: Kenji Hashimoto

Locations

3 EU/EEA countries · 12 investigational sites

By country

Country	MS status	Planned subjects	Sites
Bulgaria	Authorised, recruitment pending	10	4
Germany	Ongoing, recruiting	40	5
Poland	Authorised, recruitment pending	8	3
Rest of world	—	0	—

Investigational sites

Bulgaria

4 sites · Authorised, recruitment pending

Medical Center Excelsior OOD

Not applicable, Lozenets, Ulitsa Golo Birdo 4, Sofiya

Medical Center Medconsult Pleven OOD

Dermatology, Floor 4, Ulitsa Sveti Sveti Kiril I Metodiy 18, Pleven

Medical Center Etika Ambulatory For Specialized Outpatient Medical Care OOD

Not applicable, Ulitsa Tundzha 2, 4002, Plovdiv

Medical Center Medconsult Pleven OOD

Dermatology, Ulitsa Tirgovska 12, 5500, Lovech

Germany

5 sites · Ongoing, recruiting

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR

Dermatology, Langenbeckstrasse 1, Oberstadt, Mainz

Universitaetsklinikum Schleswig-Holstein AöR

Dermatology, Venereology and Allergology, Arnold-Heller-Strasse 3, Brunswik, Kiel

Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR

Dermatology, Fetscherstrasse 74, Johannstadt-Nord, Dresden

DRK Kliniken Berlin

Early Phase Clinical Unit (EPCU) Berlin, Spandauer Damm 130, 14050, Berlin

Universitaetsklinikum Tuebingen AöR

Dermatology, Liebermeisterstrasse 25, Innenstadt, Tuebingen

Poland

3 sites · Authorised, recruitment pending

Dermaceum Sp. z o.o.

DERMACEUM Centrum Medyczne, Ul. Zygmunta Krasinskiego 29, 50-449, Wroclaw

Dermedic Jacek Zdybski

Dermatology, ul. Klonowa 107/L7, 25-553, Kielce

Labderm Essence Sp. z o.o.

Dermatology, Ul. Lesna 2a, Ossy, Ozarowice

Country notifications

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

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Germany	2025-10-27		2025-10-29

Application history

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

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2025-06-26	Germany	Acceptable 2025-09-29	2025-10-01
2	SUBSTANTIAL MODIFICATION	SM-1	2025-12-09	Germany	Acceptable 2026-01-28	2026-01-29