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NCT Number: NCT07433179

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

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effects of oral SEP-479 in healthy adult participants.

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Key information

Conditions

Healthy Volunteers

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects who are able and willing to provide informed consent
  • Aged 21 to 60 years at the time of consent
  • Have a BMI within the range 18.0 to 32.0 kg/m2
  • In general good health

Exclusion criteria

  • Any condition, which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol.
  • Have clinically significant abnormalities on clinical laboratory results.
  • Participation in other clinical trials recently/currently

Treatment and study plan

SEP-479

Drug

Oral, capsule

Placebo

Other

Oral, capsule

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

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

    Maximum Plasma Concentration (Cmax) of SEP-479

  2. Plasma PK of SEP-479 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-479

  3. Plasma PK of SEP-479 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-479

  4. Plasma PK of SEP-479 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-479

  5. Plasma PK of SEP-479 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-479

Sponsors and collaborators

Lead sponsor

Septerna, Inc.

Industry

Registry information

Official study title

A Phase 1 Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SEP-479 in Healthy Adult Participants

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 25, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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