Healthy ParticipantsPhase 1NCT06782477
A Study of STAR-0310 in Healthy Adult Participants
A Phase 1 study testing STAR-0310 in people with Healthy Participants, run by Astria Therapeutics, Inc. at 1 site in United States.
Trial summary
This is a randomized, double-blind, placebo-controlled, single ascending dose trial evaluating the safety, tolerability, PK, and immunogenicity of STAR-0310 in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- STAR-0310
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2025to Jan 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Good health as determined by the Investigator based upon a medical evaluation.
- Body mass index (BMI) of 18 to 35 kg/m2 with a weight of at least 60 kg for men and at least 50 kg for women, with a maximum weight of 130 kg for any participant.
- Participants of childbearing potential must have a negative serum pregnancy test at Screening, agree to use highly effective forms of contraception and abstain from egg donation or fertility treatment
- Participants capable of producing sperm must use an effective method of contraception and abstain from sperm donation
- Healthy adults of Japanese descent, where both biological parents and all 4 biological grandparents are of Japanese ethnicity (applicable only for potential cohort of participants of Japanese descent).
Who cannot join
- Prior or ongoing medical condition that, in the Investigator's opinion, could adversely affect the safety of the participant.
- Known sensitivity to the ingredients of STAR-0310
- Taking any prescription or non-prescription medications within at least 5 half-lives or 7 days, whichever is longer, before the time of admission
- History of exposure to any biologic medication within 90 days or 5 half-lives, whichever is longer, before the time of admission
- Participation in a clinical trial involving receipt of an investigational product within 30 days (small molecule) or 90 days (biologics), or 5 half-lives, whichever is longer, before the time of admission
Trial locations and contacts
1 site in 1 country.
United States1 site
Austin Clinical Research Unit - Early Clinical Development
Austin, Texas, 78744
About this study
Official title: A First-in-Human, Phase 1a, Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, Single Ascending Dose Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of STAR-0310 in Healthy Adult Participants
This is a randomized, double-blind, placebo-controlled, single ascending dose trial evaluating the safety, tolerability, PK, and immunogenicity of STAR-0310 in healthy adult participants. There are 4 planned cohorts and potentially up to 1 additional cohort which may comprise of healthy adult participants of Japanese descent.
- Conditions
- Healthy Participants
- Being tested
- STAR-0310, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STAR-0310Drug
STAR-0310 will be administered as a subcutaneous bolus injection.
PlaceboDrug
Placebo will be administered as a subcutaneous bolus injection.
| Study group | Role | What they receive |
|---|---|---|
| STAR-0310 Dose 1 | Experimental | Participants will be randomized to receive STAR-0310 or matching placebo Receives: Drug: STAR-0310; Drug: Placebo |
| STAR-0310 Dose 2 | Experimental | Participants will be randomized to receive STAR-0310 or matching placebo Receives: Drug: STAR-0310; Drug: Placebo |
| STAR-0310 Dose 3 | Experimental | Participants will be randomized to receive STAR-0310 or matching placebo Receives: Drug: STAR-0310; Drug: Placebo |
| STAR-0310 Dose 4 | Experimental | Participants will be randomized to receive STAR-0310 or matching placebo Receives: Drug: STAR-0310; Drug: Placebo |
| STAR-0310 in Participants of Japanese Descent | Experimental | Participants will be randomized to receive STAR-0310 or matching placebo Receives: Drug: STAR-0310; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Treatment-emergent Adverse Events
Measured: [Time Frame: Day 1 through Day 252]
Secondary outcomes (2)
Serum Concentration of STAR-0310
Blood samples will be collected to measure the serum concentration of STAR-0310 before and after study drug administration.
Measured: [Time Frame: Day 1 (predose up to 2 hours before study drug administration, and 12 hours post dose), Days 2, 3, 7, 10, 14, 21, 28, 42, 56, 84, 112, 140, 168, 196, 224, 252 ]
Number of Participants with Anti-drug Antibodies to STAR-0310
Blood samples will be collected to assess the formation of STAR-0310 anti-drug antibodies in serum before and after study drug administration.
Measured: [Time Frame: Day 1 predose, Days 14, 28, 84, 168, 252 ]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start7 Jan 2025
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Astria Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782477
- Sponsor's protocol ID
- STAR-0310-101
- Status last verified
- Oct 2025
- First submitted
- 15 Jan 2025
- Last updated
- 4 Nov 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human, Phase 1a, Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, Single Ascending Dose Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of STAR-0310 in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06782477
- Acronym / sponsor ID
- STAR-0310-101
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Astria Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 20 Jan 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.
This is a randomized, double-blind, placebo-controlled, single ascending dose trial evaluating the safety, tolerability, PK, and immunogenicity of STAR-0310 in healthy adult participants. There are 4 planned cohorts and potentially up to 1 additional cohort which may comprise of healthy adult participants of Japanese descent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| STAR-0310 Dose 1 | Experimental | Drug: STAR-0310, Drug: PlaceboParticipants will be randomized to receive STAR-0310 or matching placebo |
| STAR-0310 Dose 2 | Experimental | Drug: STAR-0310, Drug: PlaceboParticipants will be randomized to receive STAR-0310 or matching placebo |
| STAR-0310 Dose 3 | Experimental | Drug: STAR-0310, Drug: PlaceboParticipants will be randomized to receive STAR-0310 or matching placebo |
| STAR-0310 Dose 4 | Experimental | Drug: STAR-0310, Drug: PlaceboParticipants will be randomized to receive STAR-0310 or matching placebo |
| STAR-0310 in Participants of Japanese Descent | Experimental | Drug: STAR-0310, Drug: PlaceboParticipants will be randomized to receive STAR-0310 or matching placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Good health as determined by the Investigator based upon a medical evaluation.
- Body mass index (BMI) of 18 to 35 kg/m2 with a weight of at least 60 kg for men and at least 50 kg for women, with a maximum weight of 130 kg for any participant.
- Participants of childbearing potential must have a negative serum pregnancy test at Screening, agree to use highly effective forms of contraception and abstain from egg donation or fertility treatment
- Participants capable of producing sperm must use an effective method of contraception and abstain from sperm donation
- Healthy adults of Japanese descent, where both biological parents and all 4 biological grandparents are of Japanese ethnicity (applicable only for potential cohort of participants of Japanese descent).
Key exclusion criteria (5 listed)
- Prior or ongoing medical condition that, in the Investigator's opinion, could adversely affect the safety of the participant.
- Known sensitivity to the ingredients of STAR-0310
- Taking any prescription or non-prescription medications within at least 5 half-lives or 7 days, whichever is longer, before the time of admission
- History of exposure to any biologic medication within 90 days or 5 half-lives, whichever is longer, before the time of admission
- Participation in a clinical trial involving receipt of an investigational product within 30 days (small molecule) or 90 days (biologics), or 5 half-lives, whichever is longer, before the time of admission
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 |
|---|---|---|
| STAR-0310STAR-0310 will be administered as a subcutaneous bolus injection. | Drug | STAR-0310 Dose 1, STAR-0310 Dose 2, STAR-0310 Dose 3, STAR-0310 Dose 4, STAR-0310 in Participants of Japanese Descent |
| PlaceboPlacebo will be administered as a subcutaneous bolus injection. | Drug | STAR-0310 Dose 1, STAR-0310 Dose 2, STAR-0310 Dose 3, STAR-0310 Dose 4, STAR-0310 in Participants of Japanese Descent |
Primary outcome
Number of Participants Experiencing Treatment-emergent Adverse Events
Time frame: [Time Frame: Day 1 through Day 252]
2 secondary outcomes
Serum Concentration of STAR-0310
Time frame: [Time Frame: Day 1 (predose up to 2 hours before study drug administration, and 12 hours post dose), Days 2, 3, 7, 10, 14, 21, 28, 42, 56, 84, 112, 140, 168, 196, 224, 252 ]
Number of Participants with Anti-drug Antibodies to STAR-0310
Time frame: [Time Frame: Day 1 predose, Days 14, 28, 84, 168, 252 ]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
- Individual participant dataSharing planned: No
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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 STAR-0310 in people with Healthy Participants, run by Astria Therapeutics, Inc. at 1 site in United States.
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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2025. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of Participants Experiencing Treatment-emergent Adverse Events (time frame: [Time Frame: Day 1 through Day 252]). 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 4 Nov 2025.