A Study to Evaluate Single and Multiple Doses of SEP-631 in Healthy Adult Volunteers

April 16, 2026 updated by: Septerna, Inc.

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 purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effects of oral SEP-631 in healthy adult volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Melbourne, Australia
        • Nucleus Network Melbourne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Subjects who are able and willing to provide informed consent
  2. Aged 18 to 60 years at the time of consent
  3. Have a BMI within the range 18.5 to 32.0 kg/m2
  4. In general good health

Exclusion Criteria:

  1. Any condition, which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol.
  2. Have a history of any severe allergic reaction or anaphylaxis
  3. Have clinically significant abnormalities on clinical laboratory results.
  4. Participation in other clinical trials recently/currently

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Food Effect
Drug: SEP-631
Oral, tablet
Experimental: Single Ascending Dose
Drug: SEP-631
Oral, tablet
Other: Placebo
Oral, tablet
Experimental: Multiple Ascending Dose
Drug: SEP-631
Oral, tablet
Other: Placebo
Oral, tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of treatment emergent adverse events
Time Frame: From enrollment to end of follow up visit, up to approximately 2 months
From enrollment to end of follow up visit, up to approximately 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma PK of SEP-631 after single and multiple doses
Time Frame: From enrollment to end of treatment period, up to approximately 14 days
Maximum Plasma Concentration (Cmax) of SEP-631
From enrollment to end of treatment period, up to approximately 14 days
Plasma PK of SEP-631 under fed and fasted conditions
Time Frame: From enrollment to end of treatment period, up to approximately 14 days
Maximum Plasma Concentration (Cmax) of SEP-631
From enrollment to end of treatment period, up to approximately 14 days
Plasma PK of SEP-631 after single and multiple doses
Time Frame: From enrollment to end of treatment period, up to approximately 14 days
Elimination half=life (T 1/2) of SEP-631
From enrollment to end of treatment period, up to approximately 14 days
Plasma PK of SEP-631 after single and multiple doses
Time Frame: From enrollment to end of treatment period, up to approximately 14 days
Area Under the Concentration-time Curve (AUC) of SEP-631
From enrollment to end of treatment period, up to approximately 14 days
Plasma PK of SEP-631 under fed and fasted conditions
Time Frame: From enrollment to end of treatment period, up to approximately 14 days
Area Under the Concentration-time Curve (AUC) of SEP-631
From enrollment to end of treatment period, up to approximately 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Septerna, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2025

Primary Completion (Actual)

December 18, 2025

Study Completion (Actual)

December 18, 2025

Study Registration Dates

First Submitted

June 30, 2025

First Submitted That Met QC Criteria

July 7, 2025

First Posted (Actual)

July 16, 2025

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • SEP-631-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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