Trial Profile

A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of SEP-631 in Healthy Adult Volunteers

Status: Completed

Phase of Trial: Phase I

Latest Information Update: 24 Apr 2026

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At a glance

21 Apr 2026 Status changed to completed.
01 Mar 2026 According to a Septerna media release, based on results of this study, company plans to advance SEP-631 into Phase 2 development for chronic spontaneous urticaria (CSU) and continue evaluation of additional mast cell-driven indications.
01 Mar 2026 Positive results presented in the Septerna Media Release.

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