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RecruitingNCT07433179Updated Apr 22, 2026

A Study to Evaluate Single and Multiple Doses of SEP-479 in Healthy Adult Participants

A Phase 1 interventional study of SEP-479 and Placebo in Healthy Volunteers, sponsored by Septerna, Inc.. Recruiting at 1 site in Australia. Open to participants aged 21 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-22.

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

From the registry’s dates

  • Started Mar 2026; still recruiting 7 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
21 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-479 in healthy adult participants.

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
21 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 21 to 60 years at the time of consent
  3. Have a BMI within the range 18.0 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 clinically significant abnormalities on clinical laboratory results.
  3. Participation in other clinical trials recently/currently
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Single Ascending Dose

    Drug: SEP-479 · Other: Placebo

  • Experimental
    Multiple Ascending Dose

    Drug: SEP-479 · Other: Placebo

  • Experimental
    Food Effect

    Drug: SEP-479

Interventions

  • DrugSEP-479

    Oral, capsule

  • OtherPlacebo

    Oral, capsule

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-479 after single and multiple doses

    Maximum Plasma Concentration (Cmax) of SEP-479

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

  2. Plasma PK of SEP-479 after single and multiple doses

    Elimination half-life (T 1/2) of SEP-479

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

  3. Plasma PK of SEP-479 under fed and fasted conditions

    Maximum Plasma Concentration (Cmax) of SEP-479

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

  4. Plasma PK of SEP-479 after single and multiple doses

    Area Under the Concentration-time Curve (AUC) of SEP-479

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

  5. Plasma PK of SEP-479 under fed and fasted conditions

    Area Under the Concentration-time Curve (AUC) of SEP-479

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

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07433179
Lead sponsor
Septerna, Inc.
Responsible party
Sponsor
First posted
Feb 25, 2026
Start date
Mar 4, 2026
Primary completion
Feb 2027 (estimated)
Completion
Feb 2027 (estimated)
Last update
Apr 22, 2026

Oversight

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

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No contact was published for this record. The registry link below has the sponsor’s details.

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Septerna, Inc.

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