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CompletedNCT07069036Updated Apr 21, 2026

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

A Phase 1 interventional study of SEP-631 and Placebo in Healthy Volunteers, sponsored by Septerna, Inc.. Completed at 1 site in Australia. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-21.

Sponsored by Septerna, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

Septerna, Inc. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    Single Ascending Dose

    Drug: SEP-631 · Other: Placebo

  • Experimental
    Multiple Ascending Dose

    Drug: SEP-631 · Other: Placebo

  • Experimental
    Food Effect

    Drug: SEP-631

Interventions

  • DrugSEP-631

    Oral, tablet

  • OtherPlacebo

    Oral, tablet

06

What researchers measure

Primary outcomes

  1. Frequency of treatment emergent adverse events

    Time frame: From enrollment to end of follow up visit, up to approximately 2 months

Secondary outcomes

  1. Plasma PK of SEP-631 after single and multiple doses

    Maximum Plasma Concentration (Cmax) of SEP-631

    Time frame: From enrollment to end of treatment period, up to approximately 14 days

  2. Plasma PK of SEP-631 under fed and fasted conditions

    Maximum Plasma Concentration (Cmax) of SEP-631

    Time frame: From enrollment to end of treatment period, up to approximately 14 days

  3. Plasma PK of SEP-631 after single and multiple doses

    Elimination half=life (T 1/2) of SEP-631

    Time frame: From enrollment to end of treatment period, up to approximately 14 days

  4. Plasma PK of SEP-631 after single and multiple doses

    Area Under the Concentration-time Curve (AUC) of SEP-631

    Time frame: From enrollment to end of treatment period, up to approximately 14 days

  5. Plasma PK of SEP-631 under fed and fasted conditions

    Area Under the Concentration-time Curve (AUC) of SEP-631

    Time frame: From enrollment to end of treatment period, up to approximately 14 days

07

Study locations

1 site
  • Nucleus Network Melbourne
    Melbourne, Australia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07069036
Lead sponsor
Septerna, Inc.
Responsible party
Sponsor
First posted
Jul 16, 2025
Start date
Jul 15, 2025
Primary completion
Dec 18, 2025
Completion
Dec 18, 2025
Last update
Apr 21, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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Septerna, Inc.

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