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SEP-479

Phase 1

Healthy Volunteers | Small molecule | Other |Septerna, Inc.|Last Updated: Apr 22, 2026

Target and mechanism

Molecular targetPTH1R
Target classGpcr
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment150

FDA Designations

No designations recorded

Clinical trial landscape

SEP-479 · 1 trial · 1 indication

Phase 1 1
NCT07433179A Study to Evaluate Single and Multiple Doses of SEP-479 in Healthy Adult ParticipantsHealthy Volunteers
RECRUITING150 Analytics
PHASE1RECRUITING
A Study to Evaluate Single and Multiple Doses of SEP-479 in Healthy Adult Participants
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Study Endpoints

Primary Endpoints

Frequency of treatment emergent adverse events
From enrollment to end of follow up visit, up to approximately 2 months

Secondary Endpoints

Plasma PK of SEP-479 after single and multiple doses
From enrollment to end of treatment period, up to approximately 14 days
Plasma PK of SEP-479 under fed and fasted conditions
From enrollment to end of treatment period, up to approximately 14 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Single Ascending DoseEXPERIMENTAL -
Multiple Ascending DoseEXPERIMENTAL -
Food EffectEXPERIMENTAL -

Interventions

NameTypeDescription
SEP-479DRUGOral, capsule
PlaceboOTHEROral, capsule
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Eligibility Criteria

Age Range21 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:Australia
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Frequently asked questions about SEP-479

What is SEP-479?

SEP-479 is an investigational small molecule being developed by Septerna, Inc. (NASDAQ: SEPN). It is currently in Phase 1 clinical development for use in healthy volunteers. The drug is being studied in a randomized, double-blind, controlled trial to evaluate its safety and tolerability.

What does SEP-479 target?

SEP-479 targets the parathyroid hormone 1 receptor (PTH1R), which is a G protein-coupled receptor (GPCR). By targeting this receptor, the drug may modulate pathways related to calcium and phosphate metabolism, though its exact therapeutic application has not been specified.

Who is developing SEP-479?

SEP-479 is being developed by Septerna, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol SEPN. The company is conducting a Phase 1 clinical trial of SEP-479 in healthy adult participants.

What phase is SEP-479 in?

SEP-479 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to evaluate single and multiple doses of the drug.

What clinical trials is SEP-479 in?

SEP-479 is being studied in a Phase 1 clinical trial with the identifier NCT07433179. The trial, titled "A Study to Evaluate Single and Multiple Doses of SEP-479 in Healthy Adult Participants," is recruiting 150 healthy volunteers in Australia. It is randomized, double-blind, and controlled.

Is SEP-479 being tested in healthy volunteers?

Yes, SEP-479 is being tested in healthy volunteers. The Phase 1 clinical trial NCT07433179 enrolls healthy adult participants aged 21 years and older, of all sexes. The study is designed to assess the safety, tolerability, and pharmacokinetics of single and multiple doses of SEP-479.