Single and multiple oral doses of SEP-479 in healthy adults
A Phase 1 Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SEP-479 in Healthy Adult Participants
PHASE1 · Septerna, Inc. · NCT07433179
This study will try single and repeated oral doses of SEP-479 and placebo in healthy adults to see if the drug is safe, how the body handles it, and whether food changes its effects.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 21 Years to 60 Years |
| Sex | All |
| Sponsor | Septerna, Inc. (industry) |
| Locations | 1 site (Melbourne) |
| Trial ID | NCT07433179 on ClinicalTrials.gov |
What this trial studies
This Phase 1 interventional study enrolls healthy adults aged 21–60 with BMI 18.0–32.0 kg/m2 to receive single and multiple oral doses of SEP-479 or placebo. Participants will be monitored for safety and tolerability and will have blood sampling for pharmacokinetic and pharmacodynamic measurements, along with routine clinical labs and vital sign assessments. A food-effect component will examine how a meal alters SEP-479 absorption. Results will inform dosing, safety, and design of later patient trials.
Who should consider this trial
Good fit: Healthy adults aged 21–60 with BMI 18.0–32.0 kg/m2 who are in general good health and able to give informed consent are ideal candidates.
Not a fit: People with clinically significant medical conditions, abnormal laboratory results, recent or current participation in other clinical trials, or those outside the age or BMI ranges are unlikely to benefit from participating.
Why it matters
Potential benefit: If SEP-479 is safe, well tolerated, and shows predictable pharmacokinetics, the data could enable further patient studies of the drug.
How similar studies have performed: Single- and multiple-dose Phase 1 studies are a standard early-human approach and many drugs progress after favorable safety and PK results, but there are no published results specific to SEP-479 available.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Subjects who are able and willing to provide informed consent 2. Aged 21 to 60 years at the time of consent 3. Have a BMI within the range 18.0 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 clinically significant abnormalities on clinical laboratory results. 3. Participation in other clinical trials recently/currently
Where this trial is running
Melbourne
- Nucleus Network — Melbourne, Australia (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Healthy Volunteers