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

Septerna, Inc.

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: SEP-631; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07069036

SEP-631-101

Details and patient eligibility

About

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

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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150 participants in 3 patient groups

Single Ascending Dose

Experimental group

Treatment:

Other: Placebo

Drug: SEP-631

Multiple Ascending Dose

Experimental group

Treatment:

Other: Placebo

Drug: SEP-631

Food Effect

Experimental group

Treatment:

Drug: SEP-631