A Phase I Study to Evaluate the Safety, Tolerability, and Efficacy of LAD106 in Healthy Volunteers
- Trial ID
- 2025-523328-31-00
- Protocol
- M-27312-01
- Sponsor
- Almirall S.A.
Trial statistics
Objectives
The primary objective of this study is to evaluate the safety and tolerability of LAD106 in healthy volunteers. This assessment is clinically significant for characterizing the initial safety profile of the investigational product prior to broader application in patients with inflammatory diseases. The study also aims to determine the efficacy of the compound.
Participants
The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers of both male and female genders within the age range of 18 to 30 years. Participants are characterized by the absence of inflammatory diseases.
Plans and Procedures
This Phase 1 clinical trial is designed to evaluate the safety, tolerability, and effectiveness of the investigational product LAD106 in healthy volunteers. The study utilizes a research methodology to assess the pharmacological profile of the drug. The sequence of study procedures begins with a screening visit to determine eligibility. Subsequent follow-up visits are scheduled to monitor clinical parameters, concluding with an end-of-study visit. The total duration of participant involvement is determined by the specific protocol requirements. Early termination of participation may occur based on predefined clinical conditions or safety criteria.
Treatment
Efficacy
The assessment of efficacy in this clinical trial involving inflammatory diseases is not specified.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
The Netherlands | Recruiting | 02 Feb 2026 | — |
Netherlands | — | — | 93 |

