Spyre Therapeutics, Inc. announced that it has initiated dosing of healthy volunteers in its first clinical trial of SPY001. The SPY001 Phase 1 trial is a double blind, placebo-controlled study in healthy volunteers and consists of a single-ascending dose (SAD) component and a multi-ascending dose (MAD) component. The study is expected to enroll approximately 48 healthy adult participants into four SAD cohorts and two MAD cohorts.

The primary endpoint is safety, with pharmacokinetics (PK) serving as a secondary endpoint. The company expects interim safety and PK data from this trial by year-end 2024. Pending data from the Phase 1 trial, the company anticipates progressing into Phase 2 development with SPY001 in 2025.