Hereditary AngioedemaPhase 1NCT05477160
A Study of STAR-0215 in Healthy Adult Participants
A Phase 1 study testing STAR-0215 (SC) and STAR-0215 (IV) in people with Hereditary Angioedema, run by Astria Therapeutics, Inc. at 1 site in United States.
Trial summary
This is a first-in-human, single-center, randomized, double-blind, placebo-controlled, single ascending dose study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single subcutaneous (SC) or intravenous (IV) administration of STAR-0215 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
- Hereditary Angioedema
- What is being tested?
- STAR-0215 (SC) and STAR-0215 (IV)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2022to 17 Nov 2023
- 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
- Good health as determined by the Investigator based upon a medical evaluation, including medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory measurements. Assessments may be repeated per Investigator discretion.
- Body mass index of 18 to 35 kilograms (kg)/square meter 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.
- Female participants capable of becoming pregnant must have a negative serum pregnancy test at Screening, not be nursing, and must agree to use an effective method of contraception and abstain from egg donation or fertility treatment.
- Male participants must agree to use an effective method of contraception and abstain from sperm donation.
Who cannot join
- Prior or ongoing medical condition (for example, gastrointestinal, renal, hepatic, dermatological, neurological or psychiatric, cardiovascular, respiratory, or hematological), medical history, physical examination, vital signs, ECG, or clinical laboratory abnormality that, in the Investigator's opinion, could adversely affect the safety of the participant. Assessments may be repeated once prior to dosing as needed per Investigator discretion.
- Known sensitivity to the ingredients in STAR-0215.
- Regular use of prescription or non-prescription drugs unless Investigator believes the medication(s) will not interfere with the study or compromise participant safety.
- Participation in a recent clinical study involving receipt of an investigational product within 30 days prior to the first dose of study drug or exposure to more than 4 investigational products within 12 months prior to the first dose of study drug.
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Clinical Research, LLC
West Bend, Wisconsin, 53095
About this study
Official title: A First-in-Human, Phase 1a, Randomized, Double-Blind, Placebo Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of STAR-0215 in Healthy Adult Subjects
This is a first-in-human, single-center, randomized, double-blind, placebo-controlled, single ascending dose study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single subcutaneous (SC) or intravenous (IV) administration of STAR-0215 in healthy adult participants.
- Conditions
- Hereditary Angioedema
- Being tested
- STAR-0215 (SC), Placebo (SC), STAR-0215 (IV), Placebo (IV)
- Keywords
- HAE, Angioedema
- Medical subject headings
- Angioedemas, Hereditary, Angioedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STAR-0215 (SC)Drug
STAR-0215 will be administered as an SC bolus injection.
Placebo (SC)Drug
Placebo will be administered as an SC bolus injection.
STAR-0215 (IV)Drug
STAR-0215 will be administered as an IV bolus injection.
Placebo (IV)Drug
Placebo will be administered as an IV bolus injection.
| Study group | Role | What they receive |
|---|---|---|
| STAR-0215 Dose 1 | Experimental | Participants will be randomized to receive STAR-0215 or placebo. Receives: Drug: STAR-0215 (SC); Drug: Placebo (SC) |
| STAR-0215 Dose 2 | Experimental | Participants will be randomized to receive STAR-0215 or placebo. Receives: Drug: STAR-0215 (SC); Drug: Placebo (SC) |
| STAR-0215 Dose 3 | Experimental | Participants will be randomized to receive STAR-0215 or placebo. Receives: Drug: STAR-0215 (SC); Drug: Placebo (SC) |
| STAR-0215 Dose 4 | Experimental | Participants will be randomized to receive STAR-0215 or placebo. Receives: Drug: STAR-0215 (SC); Drug: Placebo (SC) |
| STAR-0215 Dose 5 | Experimental | Participants will be randomized to receive STAR-0215 or placebo. Receives: Drug: STAR-0215 (IV); Drug: Placebo (IV) |
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: Day 1 through Day 224
Secondary outcomes (3)
Serum Concentration of STAR-0215
Blood samples will be collected to measure the serum concentration of STAR-0215 before and after study drug administration.
Measured: Day 1 (pre-dose, up to 2 hours before study drug administration, and 2, 6, 12, 24, 48, 72, 96, and 120 hours post-dose); Days 14, 28, 56, 84, 112, 140, 168, 196, and 224
Plasma Levels of Cleaved High-molecular-weight Kininogen
Blood samples will be collected to measure the plasma levels of cleaved high-molecular-weight kininogen (a measure of plasma kallikrein activity).
Measured: Day 1 (pre-dose, up to 2 hours before study drug administration, and 2, 6, 12, 24, 48, 72, 96, and 120 hours post-dose); Days 14, 28, 56, 84, 112, 140, 168, 196, and 224
Number of Participants with Anti-drug Antibodies to STAR-0215
Blood samples will be collected to assess the formation of STAR-0215 anti-drug antibodies in serum before and after study drug administration.
Measured: Day 1 (pre-dose, up to 2 hours before study drug administration); Days 28, 56, 84, 112, 140, 168, 196, and 224
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start27 Jul 2022
- Primary completion17 Nov 2023
- Study completion17 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hereditary AngioedemaStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astria Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05477160
- Sponsor's protocol ID
- STAR-0215-101
- Status last verified
- Jan 2024
- First submitted
- 26 Jul 2022
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lumry W, Gunsior M, Cohen T, Bernard K, Gustafson P, Chung JK, Morabito C. Safety and pharmacokinetics of long-acting plasma kallikrein inhibitor navenibart (STAR-0215) in healthy adults. Ann Allergy Asthma Immunol. 2025 Jul;135(1):103-111.e2. doi: 10.1016/j.anai.2025.03.016. Epub 2025 Mar 28.
PubMed 40158724
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human, Phase 1a, Randomized, Double-Blind, Placebo Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of STAR-0215 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05477160
- Acronym / sponsor ID
- STAR-0215-101
- Conditions
- Hereditary Angioedema
- Keywords
- HAE, Angioedema
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Astria Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Jul 2022 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 17 Nov 2023 (actual)
- First posted
- 28 Jul 2022 (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 first-in-human, single-center, randomized, double-blind, placebo-controlled, single ascending dose study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single subcutaneous (SC) or intravenous (IV) administration of STAR-0215 in healthy adult participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| STAR-0215 Dose 1 | Experimental | Drug: STAR-0215 (SC), Drug: Placebo (SC)Participants will be randomized to receive STAR-0215 or placebo. |
| STAR-0215 Dose 2 | Experimental | Drug: STAR-0215 (SC), Drug: Placebo (SC)Participants will be randomized to receive STAR-0215 or placebo. |
| STAR-0215 Dose 3 | Experimental | Drug: STAR-0215 (SC), Drug: Placebo (SC)Participants will be randomized to receive STAR-0215 or placebo. |
| STAR-0215 Dose 4 | Experimental | Drug: STAR-0215 (SC), Drug: Placebo (SC)Participants will be randomized to receive STAR-0215 or placebo. |
| STAR-0215 Dose 5 | Experimental | Drug: STAR-0215 (IV), Drug: Placebo (IV)Participants will be randomized to receive STAR-0215 or placebo. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Good health as determined by the Investigator based upon a medical evaluation, including medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory measurements. Assessments may be repeated per Investigator discretion.
- Body mass index of 18 to 35 kilograms (kg)/square meter 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.
- Female participants capable of becoming pregnant must have a negative serum pregnancy test at Screening, not be nursing, and must agree to use an effective method of contraception and abstain from egg donation or fertility treatment.
- Male participants must agree to use an effective method of contraception and abstain from sperm donation.
Key exclusion criteria (4 listed)
- Prior or ongoing medical condition (for example, gastrointestinal, renal, hepatic, dermatological, neurological or psychiatric, cardiovascular, respiratory, or hematological), medical history, physical examination, vital signs, ECG, or clinical laboratory abnormality that, in the Investigator's opinion, could adversely affect the safety of the participant. Assessments may be repeated once prior to dosing as needed per Investigator discretion.
- Known sensitivity to the ingredients in STAR-0215.
- Regular use of prescription or non-prescription drugs unless Investigator believes the medication(s) will not interfere with the study or compromise participant safety.
- Participation in a recent clinical study involving receipt of an investigational product within 30 days prior to the first dose of study drug or exposure to more than 4 investigational products within 12 months prior to the first dose of study drug.
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-0215 (SC)STAR-0215 will be administered as an SC bolus injection. | Drug | STAR-0215 Dose 1, STAR-0215 Dose 2, STAR-0215 Dose 3, STAR-0215 Dose 4 |
| Placebo (SC)Placebo will be administered as an SC bolus injection. | Drug | STAR-0215 Dose 1, STAR-0215 Dose 2, STAR-0215 Dose 3, STAR-0215 Dose 4 |
| STAR-0215 (IV)STAR-0215 will be administered as an IV bolus injection. | Drug | STAR-0215 Dose 5 |
| Placebo (IV)Placebo will be administered as an IV bolus injection. | Drug | STAR-0215 Dose 5 |
Primary outcome
Number of Participants Experiencing Treatment-emergent Adverse Events
Time frame: Day 1 through Day 224
3 secondary outcomes
Serum Concentration of STAR-0215
Time frame: Day 1 (pre-dose, up to 2 hours before study drug administration, and 2, 6, 12, 24, 48, 72, 96, and 120 hours post-dose); Days 14, 28, 56, 84, 112, 140, 168, 196, and 224
Plasma Levels of Cleaved High-molecular-weight Kininogen
Time frame: Day 1 (pre-dose, up to 2 hours before study drug administration, and 2, 6, 12, 24, 48, 72, 96, and 120 hours post-dose); Days 14, 28, 56, 84, 112, 140, 168, 196, and 224
Number of Participants with Anti-drug Antibodies to STAR-0215
Time frame: Day 1 (pre-dose, up to 2 hours before study drug administration); Days 28, 56, 84, 112, 140, 168, 196, and 224
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 11 Jan 2024.
- Derived from this study: PubMed 40158724Lumry W, Gunsior M, Cohen T, Bernard K, Gustafson P, Chung JK, Morabito C. Safety and pharmacokinetics of long-acting plasma kallikrein inhibitor navenibart (STAR-0215) in healthy adults. Ann Allergy Asthma Immunol. 2025 Jul;135(1):103-111.e2. doi: 10.1016/j.anai.2025.03.016. Epub 2025 Mar 28.
- 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-0215 (SC) and STAR-0215 (IV) in people with Hereditary Angioedema, 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 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 11 Jan 2024. 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?
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?
Number of Participants Experiencing Treatment-emergent Adverse Events (time frame: Day 1 through Day 224). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05477160, which also lists 1 linked publication.
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 11 Jan 2024.