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This Study Has 2 Parts. The First Part Tests How Healthy Men Tolerate Different Doses of BI 730357 and How the Metabolism of Midazolam is Affected by BI 730357. The Second Part is Done in Patients With Plaque Psoriasis and Tests How Well They Tolerate BI

2017-09-13 00:23:22 | BioPortfolio

Summary

Part 1 of this trial is a Phase Ib evaluation of the safety, tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) properties of Multiple Rising Dose (MRD) administration of BI 730357 to healthy volunteers for up to 28 days.

Part 2 is a Phase II evaluation of Proof of Clinical Concept (PoCC), based on the safety, tolerability and efficacy of multiple doses of BI 730357 administered to patients with moderate-to-severe plaque Psoriasis (PsO). This study will also serve the selection of doses for the further development of BI 730357.

- The primary objective of Part 2 is based on Week 12 co-primary endpoints of Psoriasis Area and Severity Index (PASI) 75 and Static Physician Global Assessment (sPGA) 0/1, and overall safety.

- Secondary objectives are to evaluate the safety of BI 730357 through 24 weeks of treatment, and the effects of dose escalation and longer treatment duration on efficacy

Study Design

Conditions

Healthy

Intervention

BI 730357, Placebo, Midazolam

Status

Not yet recruiting

Source

Boehringer Ingelheim

Results (where available)

View Results

Links

Published on BioPortfolio: 2017-09-13T00:23:22-0400

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