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
- Sponsor
- Egle Therapeutics
Trial statistics
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
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 | Not Yet Recruiting | 01 Oct 2025 | 10 |
Germany | Recruiting | 01 Oct 2025 | 40 |
Poland | Not Yet Recruiting | 01 Oct 2025 | 8 |



