Complement Mediated Diseases Clinical Trial
Official title:
Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of a Single Ascending Dose (SAD) and a Multiple Dose (MD) of the Complement Inhibitor AMY-101. A Prospective, Single-center, Open-label, First-In-Human (FIH) Clinical Study in Healthy Male Volunteers
Safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a Single Ascending Dose (SAD) and a Multiple Dose (MD) of the complement inhibitor AMY-101. A prospective, single-center, open-label, First-In-Human (FIH) clinical study in healthy male volunteers.
AMYNDAS is developing a novel peptidic complement inhibitor AMY-101, based on the
third-generation compstatin analogue Cp40. AMY-101 is a selective inhibitor of complement
activation in humans and in NHP. It binds to the complement component C3, the central
"functional hub" that controls the upstream activation/amplification and downstream effector
functions of complement. By binding to C3, AMY-101 inhibits the cleavage of native C3 to its
active fragments C3a and C3b. As a consequence, the deposition of C3b, amplification via the
alternative pathway and all downstream complement responses are prevented. AMY-101 is being
developed to treat complement-mediated diseases, which are largely driven by aberrant C3
activation.
This first-in-human study of the C3-targeting complement inhibitor AMY-101 investigates the
safety and PK/PD profile of AMY-101 in healthy male volunteers after Single Ascending Dose
(SAD) and Multiple Doses (MD) using subcutaneous (SQ) or intravenous (IV) administration. The
study is a prospective, single-center, open-label evaluation in healthy male volunteers.
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