Septerna, Inc. ((SEPN)) announced an update on their ongoing clinical study.
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Septerna, Inc. (SEPN) is conducting a Phase 1 clinical study titled 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. The study aims to assess the safety and tolerability of the oral drug SEP-631, alongside its pharmacokinetic and pharmacodynamic properties, in healthy adult volunteers. This research is significant as it explores the potential of SEP-631 in therapeutic applications.
The intervention being tested is SEP-631, an oral tablet designed to evaluate its safety and efficacy. The study includes both single and multiple ascending doses, as well as a food effect assessment, with a placebo group for comparison.
The study design is interventional, with a randomized allocation and a sequential intervention model. It employs a quadruple masking approach, meaning that participants, care providers, investigators, and outcomes assessors are blinded to the treatment assignments. The primary purpose of the study is treatment-focused.
The study is set to begin on June 30, 2025, with the latest update submitted on July 7, 2025. These dates are crucial as they mark the initiation and the most recent progress in the study timeline, although recruitment has not yet started.
The initiation of this study could influence Septerna’s stock performance, as positive outcomes may boost investor confidence and market value. Given the competitive landscape in pharmaceutical research, advancements in SEP-631 could position Septerna favorably against industry peers.
The study is ongoing, with further details available on the ClinicalTrials portal.