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Inmagene Obtains FDA IND Clearance For BTK Inhibitor Targeting Immunological Diseases

The U.S. Food and Drug Administration cleared Inmagene Biopharmaceuticals' investigational new drug or IND application for the drug candidate IMG-004, a non-covalent, reversible, third-generation Bruton Tyrosine Kinase or BTK inhibitor, to proceed to the Phase I clinical trial.

Inmagene is developing the drug candidate to potentially treat immunological diseases.

The planned Phase 1 study is a double-blind, randomized, placebo-controlled, single and multiple dose escalation study in healthy subjects. The study aims to explore IMG-004's safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy subjects.

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