RecruitingPhase 1NCT07433179

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

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

Sponsor

Septerna, Inc.

Enrollment

150 participants

Start Date

Mar 4, 2026

Study Type

INTERVENTIONAL

Conditions

Healthy Volunteers

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.

Eligibility

Min Age: 21 YearsMax Age: 60 Years

Inclusion Criteria4

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 Criteria3

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

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Interventions

DRUGSEP-479

Oral, capsule

OTHERPlacebo

Oral, capsule

Locations(1)

Nucleus Network

Melbourne, Australia

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NCT07433179

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