assignment
Recruiting

A Phase I, Open-Label, Dose-Finding Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of EGL-003 in Healthy Volunteers and Adults with Atopic Dermatitis

Trial ID
2025-521658-40-00
Protocol
EGL-311

Trial statistics

location_city
11
research sites
public
3
countries
medical_information
1
disease
person_search
14
investigators

Diseases & Conditions

Objectives

The primary objective of this first-in-human study is to evaluate the safety, tolerability, and pharmacokinetics of EGL-003 in healthy volunteers and subsequently in adults diagnosed with atopic dermatitis. Determining these parameters is essential for establishing the initial safety profile and understanding the drug's disposition in the human body. Secondary objectives include the assessment of dose-finding parameters to support subsequent clinical development.

Participants

The sponsor did not provide information regarding the total number of participants. The study population consists of patients with atopic dermatitis and healthy volunteers. The participants include both males and females within the 3-year-old age range.

Plans and Procedures

This Phase 1, first-in-human, open-label, dose finding study is designed to evaluate the safety, tolerability, and pharmacokinetics of EGL-003. The research methodology involves an initial assessment in healthy volunteers, followed by an evaluation in adults diagnosed with atopic dermatitis. The clinical sequence includes a screening visit to determine eligibility, followed by subsequent study visits and an end-of-study visit. The total duration of participant involvement and the specific conditions for early termination are not specified.

Treatment

Please provide the source data containing the names of the medications, dosages, forms, and administration routes. Without the specific information regarding the substances to be described, it is not possible to generate the clinical trial description.

Efficacy

Efficacy assessment in this clinical trial involves the evaluation of outcomes related to atopic dermatitis.

Trial Status by Country

Country Status Start of Recruitment Planned Patients
Bulgaria BulgariaNot Yet Recruiting01 Oct 202510
Germany GermanyRecruiting01 Oct 202540
Poland PolandNot Yet Recruiting01 Oct 20258

Sites & Investigators

Conditions Studied in This Trial