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

NCT07069036 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-04-21

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

SEP-631

Oral, tablet

OTHER

Placebo

Oral, tablet

Sponsors & Collaborators

  • Septerna, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-15
Primary Completion
2025-12-18
Completion
2025-12-18

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07069036 on ClinicalTrials.gov