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A single center, phase I, partially blinded, placebo-controlled, first-in-man study to evaluate the safety, tolerability and Proof of Mechanism (PoM) of a single administration of BFH772 in healthy vo...

Mise à jour : Il y a 4 ans
Référence : EUCTR2008-002795-96

A single center, phase I, partially blinded, placebo-controlled, first-in-man study to evaluate the safety, tolerability and Proof of Mechanism (PoM) of a single administration of BFH772 in healthy volunteers, and Proof of Concept (PoC) study to evaluate the safety, tolerability, and pharmacodynamics of multiple topical administrations of BFH772 in patients with psoriasis

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Extrait

• Investigate the safety and tolerability of single and multiple doses of BFH772 in two different formulations in healthy and psoriatic subjects • Assess the efficacy of topically applied BFH772 to treat psoriasis as assessed by plaque PASI scoring at week 4. The main objective of this first-in-man study with BFH772 topical formulation, planned to demonstrate the safety and tolerability and proof of mechanism of BFH772 followed by the proof of concept of BFH772 in psoriasis patients. Two parts will be considered sequentially: Safety cohorts and Part 1: study the safety and tolerability of BFH772 after single dose in two different formulations, a cream and an ointment with two strengths of each. In addition, the proof of mechanism (PoM) of BFH772 will be assessed. The local safety and tolerability of BFH772 will be used as a decision making endpoint to progress to the Part 2 of the study. Part 2: This will be a proof of concept study (PoC) in psoriasis patients.

Critère d'inclusion

  • Plaque psoriasis

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