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: 05 Dec 2025
At a glance
- Drugs SEP 631 (Primary)
- Indications Chronic urticaria; Mastocytosis
- Focus Adverse reactions; First in man
- Sponsors Septerna
Most Recent Events
- 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.
- 15 May 2025 According to a Septerna media release, company expects to Initiate Phase 1 Trial for SEP-631, in third quarter of 2025.