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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-31

Study Completion Date

2026-04-30

Brief Summary

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The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effects of oral SEP-631 in healthy adult volunteers.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Single Ascending Dose

Group Type EXPERIMENTAL

SEP-631

Intervention Type DRUG

Oral, tablet

Placebo

Intervention Type OTHER

Oral, tablet

Multiple Ascending Dose

Group Type EXPERIMENTAL

SEP-631

Intervention Type DRUG

Oral, tablet

Placebo

Intervention Type OTHER

Oral, tablet

Food Effect

Group Type EXPERIMENTAL

SEP-631

Intervention Type DRUG

Oral, tablet

Interventions

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SEP-631

Oral, tablet

Intervention Type DRUG

Placebo

Oral, tablet

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes