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

Not Applicable

Not yet recruiting

• Conditions: Healthy Volunteers
• Interventions: Drug: SEP-631; Other: Placebo

• Registration Number: NCT07069036
• Lead Sponsor: Septerna, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-30
• Status Verified: 2025-07
• Study Start: 2025-07-01
• Study First Submitted QC: 2025-07-07
• Last Update Submitted: 2025-07-07
• Study First Posted: 2025-07-16
• Last Update Posted: 2025-07-16
• Primary Completion: 2026-03
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Single Ascending Dose	SEP-631	-
Single Ascending Dose	Placebo	-
Multiple Ascending Dose	SEP-631	-
Multiple Ascending Dose	Placebo	-
Food Effect	SEP-631	-

Primary Outcome Measures

Name	Time	Method
Frequency of treatment emergent adverse events	From enrollment to end of follow up visit, up to approximately 2 months

Secondary Outcome Measures

Name	Time	Method
Plasma PK of SEP-631 after single and multiple doses	From enrollment to end of treatment period, up to approximately 14 days	Area Under the Concentration-time Curve (AUC) of SEP-631
Plasma PK of SEP-631 under fed and fasted conditions	From enrollment to end of treatment period, up to approximately 14 days	Area Under the Concentration-time Curve (AUC) of SEP-631