Healthy VolunteersPhase 1NCT07069036
A Study to Evaluate Single and Multiple Doses of SEP-631 in Healthy Adult Volunteers
A Phase 1 study testing SEP-631 in people with Healthy Volunteers, run by Septerna, Inc. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- SEP-631
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteAustralia
- Study dates
- 15 Jul 2025to 18 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Being tested
- SEP-631, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEP-631Drug
Oral, tablet
PlaceboOther
Oral, tablet
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose | Experimental | Not described Receives: Drug: SEP-631; Other: Placebo |
| Multiple Ascending Dose | Experimental | Not described Receives: Drug: SEP-631; Other: Placebo |
| Food Effect | Experimental | Not described Receives: Drug: SEP-631 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of treatment emergent adverse events
Measured: 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
Maximum Plasma Concentration (Cmax) of SEP-631
Measured: From enrollment to end of treatment period, up to approximately 14 days
Plasma PK of SEP-631 under fed and fasted conditions
Maximum Plasma Concentration (Cmax) of SEP-631
Measured: From enrollment to end of treatment period, up to approximately 14 days
Plasma PK of SEP-631 after single and multiple doses
Elimination half=life (T 1/2) of SEP-631
Measured: From enrollment to end of treatment period, up to approximately 14 days
Plasma PK of SEP-631 after single and multiple doses
Area Under the Concentration-time Curve (AUC) of SEP-631
Measured: From enrollment to end of treatment period, up to approximately 14 days
Plasma PK of SEP-631 under fed and fasted conditions
Area Under the Concentration-time Curve (AUC) of SEP-631
Measured: From enrollment to end of treatment period, up to approximately 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start15 Jul 2025
- Primary completion18 Dec 2025
- Study completion18 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Septerna, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069036
- Sponsor's protocol ID
- SEP-631-101
- Status last verified
- Apr 2026
- First submitted
- 30 Jun 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07069036
- Acronym / sponsor ID
- SEP-631-101
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Septerna, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 18 Dec 2025 (actual)
- Study completion
- 18 Dec 2025 (actual)
- First posted
- 16 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effects of oral SEP-631 in healthy adult volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose | Experimental | Drug: SEP-631, Other: Placebo |
| Multiple Ascending Dose | Experimental | Drug: SEP-631, Other: Placebo |
| Food Effect | Experimental | Drug: SEP-631 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SEP-631Oral, tablet | Drug | Food Effect, Multiple Ascending Dose, Single Ascending Dose |
| PlaceboOral, tablet | Other | Multiple Ascending Dose, Single Ascending Dose |
Primary outcome
Frequency of treatment emergent adverse events
Time frame: From enrollment to end of follow up visit, up to approximately 2 months
5 secondary outcomes
Plasma PK of SEP-631 after single and multiple doses
Time frame: From enrollment to end of treatment period, up to approximately 14 days
Plasma PK of SEP-631 under fed and fasted conditions
Time frame: From enrollment to end of treatment period, up to approximately 14 days
Plasma PK of SEP-631 after single and multiple doses
Time frame: From enrollment to end of treatment period, up to approximately 14 days
Plasma PK of SEP-631 after single and multiple doses
Time frame: From enrollment to end of treatment period, up to approximately 14 days
Plasma PK of SEP-631 under fed and fasted conditions
Time frame: From enrollment to end of treatment period, up to approximately 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SEP-631 in people with Healthy Volunteers, run by Septerna, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of treatment emergent adverse events (time frame: From enrollment to end of follow up visit, up to approximately 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.