A Phase 1/2 interventional study of Navenibart in Hereditary Angioedema, sponsored by Astria Therapeutics, Inc.. Completed at 20 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by Astria Therapeutics, Inc. (part of BioCryst Pharmaceuticals) · Phase 1/2, Interventional, and Treatment
The goal of this clinical trial is to test the drug navenibart in participants with hereditary angioedema (HAE). One group of participants will get 1 dose of navenibart, and 2 other groups will get 2 doses of navenibart. Researchers will study the effects of navenibart in participants with HAE as this is the first time that the drug has been given to participants with HAE.
This is a Phase 1b/2 single and multiple dose trial evaluating the safety, tolerability, clinical activity, pharmacokinetics, pharmacodynamics, and immunogenicity of subcutaneous administration of navenibart in participants with type I or type II HAE in 3 dose cohorts. The first cohort will receive 1 dose of navenibart; the second and third cohorts will receive 2 sequential doses. This is the first trial of navenibart in participants with HAE and the first evaluation of a multiple-dose regimen. After the required follow up period, participants who are willing and eligible to consent can begin participation in the long-term open label extension study (STAR-0215-202, ALPHA-SOLAR; NCT06007677).
171 studies on the registry are indexed under Angioedemas, Hereditary; 24 are open to participants now.
This study's enrollment of 29 is below the median of 48 across 116 interventional studies indexed under Angioedemas, Hereditary.
Browse Angioedemas, Hereditary studies →Astria Therapeutics, Inc. is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
First submitted before Astria Therapeutics, Inc. became part of BioCryst Pharmaceuticals.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Documented diagnosis of HAE (type I or II). The following must be met:
a. Documented clinical history consistent with HAE (for example, subcutaneous or mucosal, nonpruritic swelling episodes without accompanying urticaria).
Exclusion Criteria:
Use of therapies prescribed for the prevention of HAE attacks prior to Screening:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received 1 dose (450 milligrams \[mg\]) of navenibart.
Drug: Navenibart
Participants received 2 doses (600 mg, 300 mg) of navenibart administered 3 months apart.
Drug: Navenibart
Participants received 2 doses (600 mg) of navenibart administered 1 month apart.
Drug: Navenibart
Navenibart will be administered as a subcutaneous bolus injection.
Also known as: STAR-0215
Number of Participants Experiencing Treatment-emergent Adverse Events
An adverse event was any untoward medical occurrence in a clinical investigation participant who was administered a pharmaceutical product that did not necessarily have a causal relationship with the treatment. A treatment-emergent adverse event was defined as any adverse event with an onset at the time of or following the start of treatment with study drug, or medical conditions present before the start of treatment that increased in severity or relationship at the time of or following the start of treatment. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' section.
Time frame: Day 1 through Day 448 (Cohort 1), Day 531 (Cohort 2), Day 475 (Cohort 3)
Percent Change From Baseline in Monthly Hereditary Angioedema (HAE) Attack Rate
An attack was considered an HAE attack if at least 1 of the following criteria was met (per the investigator): peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region); abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea); laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx). The HAE attack rate was the number of unique investigator-confirmed HAE attacks per month.
Time frame: Baseline, Day 168 (Cohort 1), Day 251 (Cohort 2), Day 195 (Cohort 3)
Number of Participants Who Were HAE Attack Free
An attack was considered an HAE attack if at least 1 of the following criteria was met (per the investigator): peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region); abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea); laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx).
Time frame: Baseline through Day 168 (Cohort 1), Day 251 (Cohort 2), Day 195 (Cohort 3)
Severity of HAE Attacks Experienced by Participants
An attack was considered an HAE attack if at least 1 of the following criteria was met (per the investigator): peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region); abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea); laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx). All HAE attacks were classified by the investigator according to severity: mild (transient or mild discomfort); moderate (mild to moderate limitation in activity, some assistance with daily activities needed); severe (marked limitation in activity, assistance with daily activities required).
Time frame: Day 1 through Day 168 (Cohort 1), Day 251 (Cohort 2), and Day 195 (Cohort 3)
Duration of HAE Attacks
An attack was considered an HAE attack if at least 1 of the following criteria was met (per the investigator): peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region); abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea); laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx).
Time frame: Day 1 through Day 168 (Cohort 1), Day 251 (Cohort 2), and Day 195 (Cohort 3)
Number of HAE Attacks Requiring On-demand Therapy
An attack was considered an HAE attack if at least 1 of the following criteria was met (per the investigator): peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region); abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea); laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx).
Time frame: Day 1 through Day 168 (Cohort 1), Day 251 (Cohort 2), and Day 195 (Cohort 3)
Time to First HAE Attack After First and Last Dosing
An attack was considered an HAE attack if at least 1 of the following criteria was met (per the investigator): peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region); abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea); laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx). The time to first HAE attack was calculated by: (\[First HAE attack or censor date\] - First Treatment date) +1. If a participant did not have an HAE attack, they were censored to the end of study date.
Time frame: Day 1 through Day 168 (Cohort 1), Day 251 (Cohort 2), and Day 195 (Cohort 3)
Proportion of HAE Attack-free Days
An attack was considered an HAE attack if at least 1 of the following criteria was met (per the investigator): peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region); abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea); laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx). The proportion of HAE attack-free days was calculated by: (the number of HAE attack-free days/duration of evaluation period in days).
Time frame: Day 1 through Day 168 (Cohort 1), Day 251 (Cohort 2), and Day 195 (Cohort 3)
Maximum Drug Concentration (Cmax) of Navenibart
Blood samples were collected at designated timepoints to measure the Cmax of navenibart. Results reported as micrograms/milliliter (mcg/mL).
Time frame: Day 1 (pre-dose, 4 hours post dose) up to Day 168 (Cohort 1); Day 1 (pre-dose, 4 hours post dose) up to Day 251 (Cohort 2); Day 1 (pre-dose, 4 hours post dose) up to Day 195 (Cohort 3)
Percent Change From Baseline in Plasma Levels of Cleaved High-molecular-weight Kininogen (cHMWK)
Blood samples were collected to measure the plasma levels of cHMWK (a measure of plasma kallikrein activity). Results reported as percent change in percentage cHMWK (%cHMWK). A decrease in %cHMWK is reflective of the pharmacodynamic activity of navenibart.
Time frame: Baseline, Day 56 (Cohort 1), Day 90 (Cohort 2), Day 41 (Cohort 3)
Number of Participants With Treatment-emergent Anti-drug Antibodies (ADAs) to Navenibart
Blood samples were collected at designated timepoints to assess the formation of navenibart ADAs in serum.
Time frame: Day 1 (pre-dose) up to Day 168 (Cohort 1); Day 1 (pre-dose) up to Day 251 (Cohort 2); Day 1 (pre-dose) up to Day 195 (Cohort 3)
Of the 41 participants who were recruited and screened, 29 participants were enrolled and received navenibart (STAR-0215). All enrolled participants who received navenibart were included in the safety, efficacy, pharmacokinetics, and pharmacodynamics analyses.
| Milestone | Cohort 1: Single Dose Navenibart | Cohort 2: Multiple Dose Navenibart | Cohort 3: Multiple Dose Navenibart |
|---|---|---|---|
| Started | 4 | 13 | 12 |
| Received at least 1 dose of study drug | 4 | 13 | 12 |
| Completed | 4 | 13 | 12 |
| Not completed | 0 | 0 | 0 |
An adverse event was any untoward medical occurrence in a clinical investigation participant who was administered a pharmaceutical product that did not necessarily have a causal relationship with the treatment. A treatment-emergent adverse event was defined as any adverse event with an onset at the time of or following the start of treatment with study drug, or medical conditions present before the start of treatment that increased in severity or relationship at the time of or following the start of treatment. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' section.
| Participants | Cohort 1: Single Dose Navenibart | Cohort 2: Multiple Dose Navenibart | Cohort 3: Multiple Dose Navenibart |
|---|---|---|---|
| Number of Participants Experiencing Treatment-emergent Adverse Events | 4 | 9 | 12 |
An attack was considered an HAE attack if at least 1 of the following criteria was met (per the investigator): peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region); abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea); laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx). The HAE attack rate was the number of unique investigator-confirmed HAE attacks per month.
| % change in monthly HAE attack rate | Cohort 1: Single Dose Navenibart | Cohort 2: Multiple Dose Navenibart | Cohort 3: Multiple Dose Navenibart |
|---|---|---|---|
| Percent Change From Baseline in Monthly Hereditary Angioedema (HAE) Attack Rate | -84.131 ± 23.398 | -85.225 ± 15.508 | -88.286 ± 17.677 |
An attack was considered an HAE attack if at least 1 of the following criteria was met (per the investigator): peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region); abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea); laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx).
| Participants | Cohort 1: Single Dose Navenibart | Cohort 2: Multiple Dose Navenibart | Cohort 3: Multiple Dose Navenibart |
|---|---|---|---|
| Number of Participants Who Were HAE Attack Free | 1 | 6 | 7 |
An attack was considered an HAE attack if at least 1 of the following criteria was met (per the investigator): peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region); abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea); laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx). All HAE attacks were classified by the investigator according to severity: mild (transient or mild discomfort); moderate (mild to moderate limitation in activity, some assistance with daily activities needed); severe (marked limitation in activity, assistance with daily activities required).
| Participants | Cohort 1: Single Dose Navenibart | Cohort 2: Multiple Dose Navenibart | Cohort 3: Multiple Dose Navenibart |
|---|---|---|---|
| None/Attack-free | 1 | 6 | 7 |
| Mild | 1 | 1 | 2 |
| Moderate | 2 | 6 | 2 |
| Severe | 0 | 0 | 1 |
An attack was considered an HAE attack if at least 1 of the following criteria was met (per the investigator): peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region); abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea); laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx).
| hours | Cohort 1: Single Dose Navenibart | Cohort 2: Multiple Dose Navenibart | Cohort 3: Multiple Dose Navenibart |
|---|---|---|---|
| Duration of HAE Attacks | 23.3 ± 15.9 | 37.1 ± 27.6 | 54.3 ± 59.8 |
An attack was considered an HAE attack if at least 1 of the following criteria was met (per the investigator): peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region); abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea); laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx).
| HAE attacks | Cohort 1: Single Dose Navenibart | Cohort 2: Multiple Dose Navenibart | Cohort 3: Multiple Dose Navenibart |
|---|---|---|---|
| Number of HAE Attacks Requiring On-demand Therapy | 1.0 ± 0.0 | 6.4 ± 5.3 | 3.5 ± 1.7 |
An attack was considered an HAE attack if at least 1 of the following criteria was met (per the investigator): peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region); abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea); laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx). The time to first HAE attack was calculated by: (\[First HAE attack or censor date\] - First Treatment date) +1. If a participant did not have an HAE attack, they were censored to the end of study date.
| days | Cohort 1: Single Dose Navenibart | Cohort 2: Multiple Dose Navenibart | Cohort 3: Multiple Dose Navenibart |
|---|---|---|---|
| After First Dose | 109.00 (25.00 to NA) | 241.00 (57.00 to NA) | NA (13.00 to NA) |
| After Last Dose | 109.00 (25.00 to NA) | 159.00 (28.00 to NA) | NA (49.00 to NA) |
An attack was considered an HAE attack if at least 1 of the following criteria was met (per the investigator): peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region); abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea); laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx). The proportion of HAE attack-free days was calculated by: (the number of HAE attack-free days/duration of evaluation period in days).
| proportion of HAE attack-free days | Cohort 1: Single Dose Navenibart | Cohort 2: Multiple Dose Navenibart | Cohort 3: Multiple Dose Navenibart |
|---|---|---|---|
| Proportion of HAE Attack-free Days | 0.988 ± 0.013 | 0.974 ± 0.041 | 0.984 ± 0.030 |
Blood samples were collected at designated timepoints to measure the Cmax of navenibart. Results reported as micrograms/milliliter (mcg/mL).
| mcg/mL | Cohort 1: Single Dose Navenibart | Cohort 2: Multiple Dose Navenibart | Cohort 3: Multiple Dose Navenibart |
|---|---|---|---|
| Maximum Drug Concentration (Cmax) of Navenibart | 39.170 ± 68.3 | 57.684 ± 50.0 | 119.334 ± 35.5 |
Blood samples were collected to measure the plasma levels of cHMWK (a measure of plasma kallikrein activity). Results reported as percent change in percentage cHMWK (%cHMWK). A decrease in %cHMWK is reflective of the pharmacodynamic activity of navenibart.
| percent change from baseline of %cHMWK | Cohort 1: Single Dose Navenibart | Cohort 2: Multiple Dose Navenibart | Cohort 3: Multiple Dose Navenibart |
|---|---|---|---|
| Percent Change From Baseline in Plasma Levels of Cleaved High-molecular-weight Kininogen (cHMWK) | -60.702 ± 9.216 | -51.635 ± 22.839 | -74.878 ± 13.353 |
Blood samples were collected at designated timepoints to assess the formation of navenibart ADAs in serum.
| Participants | Cohort 1: Single Dose Navenibart | Cohort 2: Multiple Dose Navenibart | Cohort 3: Multiple Dose Navenibart |
|---|---|---|---|
| Number of Participants With Treatment-emergent Anti-drug Antibodies (ADAs) to Navenibart | 2 | 3 | 6 |
Collected over Day 1 through Day 448 (Cohort 1), Day 531 (Cohort 2), Day 475 (Cohort 3). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1: Single Dose Navenibart | 0/4 (0%) | 0/4 (0%) | 4/4 (100%) |
| Cohort 2: Multiple Dose Navenibart | 0/13 (0%) | 0/13 (0%) | 9/13 (69.2%) |
| Cohort 3: Multiple Dose Navenibart | 0/12 (0%) | 0/12 (0%) | 12/12 (100%) |
| Event | Cohort 1: Single Dose Navenibart | Cohort 2: Multiple Dose Navenibart | Cohort 3: Multiple Dose Navenibart |
|---|---|---|---|
| HeadacheNervous system disorders | 2/4 | 3/13 | 2/12 |
| NasopharyngitisInfections and infestations | 1/4 | 2/13 | 4/12 |
| DysgeusiaNervous system disorders | 1/4 | 0/13 | 0/12 |
| Hyperaesthesia teethGastrointestinal disorders | 1/4 | 0/13 | 0/12 |
| Tongue geographicGastrointestinal disorders | 1/4 | 0/13 | 0/12 |
| ContusionInjury, poisoning and procedural complications | 1/4 | 0/13 | 1/12 |
| Skin lacerationInjury, poisoning and procedural complications | 1/4 | 0/13 | 1/12 |
| Limb injuryInjury, poisoning and procedural complications | 1/4 | 0/13 | 0/12 |
| Soft tissue injuryInjury, poisoning and procedural complications | 1/4 | 0/13 | 0/12 |
| Tooth injuryInjury, poisoning and procedural complications | 1/4 | 0/13 | 0/12 |
Safety Analysis Set: all participants who received any amount of navenibart.
| Age, Continuous(Years) | Cohort 1: Single Dose Navenibart | Cohort 2: Multiple Dose Navenibart | Cohort 3: Multiple Dose Navenibart | Total |
|---|---|---|---|---|
| Mean | 51.0 ± 21.2 | 43.6 ± 15.0 | 47.9 ± 17.8 | 46.4 ± 16.6 |
| Sex: Female, Male(Participants) | Cohort 1: Single Dose Navenibart | Cohort 2: Multiple Dose Navenibart | Cohort 3: Multiple Dose Navenibart | Total |
|---|---|---|---|---|
| Female | 3 | 7 | 6 | 16 |
| Male | 1 | 6 | 6 | 13 |
| Ethnicity (NIH/OMB)(Participants) | Cohort 1: Single Dose Navenibart | Cohort 2: Multiple Dose Navenibart | Cohort 3: Multiple Dose Navenibart | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 2 | 2 | 4 |
| Not Hispanic or Latino | 4 | 11 | 10 | 25 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Cohort 1: Single Dose Navenibart | Cohort 2: Multiple Dose Navenibart | Cohort 3: Multiple Dose Navenibart | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 2 | 1 | 3 |
| White | 4 | 7 | 10 | 21 |
| More than one race | 0 | 2 | 0 | 2 |
| Unknown or Not Reported | 0 | 2 | 1 | 3 |
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Studies of the drug tested here: Navenibart