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A First-in-Human PoC Study With BEN2293 in Patients With Mild to Moderate Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:
A First-in-Human, Double-Blind, Randomised, Vehicle Controlled Phase I/II Proof of Concept Study to Investigate the Safety, Tolerability, Pharmacokinetics and Efficacy of BEN2293 in Patients With Mild to Moderate Atopic Dermatitis

Clinical Trial Summary

A randomised, adaptive design, double-blind, placebo-controlled, first-in-human, two-part study to investigate the safety, tolerability, PK and preliminary efficacy of multiple topical doses of BEN2293 in patients with mild to moderate AD.

Clinical Trial Description

This Protocol will be adaptive and designed to enable knowledge gained from the previous cohort to be applied to subsequent cohorts. Changes made will be within the boundaries of the adaptive elements with clear control mechanisms and guidance for staying within these boundaries. Part A is a randomised, double-blind, placebo-controlled, sequential group study to investigate ascending multiple topical doses of BEN2293 in patients with mild to moderate AD. Patients will participate in only one cohort. Part B is a randomised, double-blind, placebo-controlled, parallel group study to investigate up to two dose regimens of topical doses of BEN2293 administered for a maximum of 28 days in patients with mild to moderate AD. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04737304
Study type Interventional
Source BenevolentAI Bio
Contact
Status Completed
Phase Phase 1/Phase 2
Start date October 14, 2020
Completion date January 26, 2023
View Details
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