A Phase 1 First-in-Human Study to Evaluate the Safety and Pharmacokinetics of SAR447754 in Healthy Adults and Adults with Moderate-to-Severe Atopic Dermatitis

The primary objective of this phase 1 first-in-human study is to evaluate the safety and tolerability of SAR447754 in healthy adult participants and in adults diagnosed with atopic dermatitis. This assessment is critical to establish the initial safety profile of the investigational product in both healthy and diseased populations.

The sponsor did not provide information regarding the total number of participants. The study population consists of patients diagnosed with atopic dermatitis and healthy volunteers. The cohort includes both male and female individuals, including vulnerable populations. The age range of the subjects is categorized under code 3.

This Phase 1, first-in-human study is designed to evaluate the safety and pharmacokinetics of SAR447754. The investigation includes both healthy adult participants and adults diagnosed with atopic dermatitis. The clinical trial design incorporates a randomized and double-blind approach to ensure objective assessment. The study sequence begins with a screening visit to determine eligibility, followed by subsequent follow-up visits to monitor participant responses. The process concludes with an end-of-study visit. The total duration of participant involvement is determined by the individual study protocol. Early termination of participation may occur based on specific predefined discontinuation criteria.

The assessment of efficacy in this phase 1 clinical trial for atopic dermatitis is not specified.