A Study to Evaluate Single and Multiple Doses of SEP-631 in Healthy Adult Volunteers
A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of SEP-631 in Healthy Adult Volunteers
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy-volunteers
Started Jul 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2025
CompletedStudy Start
First participant enrolled
July 15, 2025
CompletedFirst Posted
Study publicly available on registry
July 16, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 18, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 18, 2025
CompletedApril 21, 2026
April 1, 2026
5 months
June 30, 2025
April 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Frequency of treatment emergent adverse events
From enrollment to end of follow up visit, up to approximately 2 months
Secondary Outcomes (5)
Plasma PK of SEP-631 after single and multiple doses
From enrollment to end of treatment period, up to approximately 14 days
Plasma PK of SEP-631 under fed and fasted conditions
From enrollment to end of treatment period, up to approximately 14 days
Plasma PK of SEP-631 after single and multiple doses
From enrollment to end of treatment period, up to approximately 14 days
Plasma PK of SEP-631 after single and multiple doses
From enrollment to end of treatment period, up to approximately 14 days
Plasma PK of SEP-631 under fed and fasted conditions
From enrollment to end of treatment period, up to approximately 14 days
Study Arms (3)
Single Ascending Dose
EXPERIMENTALMultiple Ascending Dose
EXPERIMENTALFood Effect
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Subjects who are able and willing to provide informed consent
- Aged 18 to 60 years at the time of consent
- Have a BMI within the range 18.5 to 32.0 kg/m2
- In general good health
You may not qualify if:
- Any condition, which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol.
- Have a history of any severe allergic reaction or anaphylaxis
- Have clinically significant abnormalities on clinical laboratory results.
- Participation in other clinical trials recently/currently
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Septerna, Inc.lead
Study Sites (1)
Nucleus Network Melbourne
Melbourne, Australia
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2025
First Posted
July 16, 2025
Study Start
July 15, 2025
Primary Completion
December 18, 2025
Study Completion
December 18, 2025
Last Updated
April 21, 2026
Record last verified: 2026-04