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
Latest Information Update: 19 Feb 2026
At a glance
- Drugs SEP 631 (Primary)
- Indications Chronic urticaria; Mastocytosis
- Focus Adverse reactions; First in man
- Sponsors Septerna
Most Recent Events
- 11 Feb 2026 According to a Septerna media release, the company will present data from its Phase 1 clinical trial of SEP-631 at the 2026 American Academy of Allergy Asthma & Immunology (AAAAI) Annual Meeting, taking place February 27-March 2, 2026, in Philadelphia.
- 10 Nov 2025 According to a Septerna media release, data expected in the first half of 2026.
- 21 Aug 2025 According to a Septerna media release, first patient has been dosed.