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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-502953-32 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 - Single Dose | Experimental | Participants received 1 dose (450 milligrams [mg]) of navenibart. |
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| Cohort 2 - Multiple Dose | Experimental | Participants received 2 doses (600 mg, 300 mg) of navenibart administered 3 months apart. |
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| Cohort 3 - Multiple Dose | Experimental | Participants received 2 doses (600 mg) of navenibart administered 1 month apart. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Navenibart | Drug | Navenibart will be administered as a subcutaneous bolus injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 through Day 448 (Cohort 1), Day 531 (Cohort 2), Day 475 (Cohort 3) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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).
Experienced at least 2 HAE attacks during the Run-In period, as confirmed by an investigator based on meeting the protocol-specified definition of an HAE attack.
Exclusion Criteria:
Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1 inhibitor deficiency, HAE with normal C1-INH (also known as HAE type III), idiopathic angioedema, or angioedema associated with urticaria.
Use of therapies prescribed for the prevention of HAE attacks prior to Screening:
Any exposure to angiotensin-converting enzyme inhibitors or any estrogen containing medications with systemic absorption (such as hormonal contraceptives or hormone replacement therapy) within 28 days prior to Screening.
Any exposure to androgens (for example, stanozolol, danazol, oxandrolone, methyltestosterone, testosterone) within 7 days prior to Screening.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allervie Clinical Research | Birmingham | Alabama | 35209 | United States | ||
| Medical Research of Arizona a Division of Allergy, Asthma & Immunology Associates, LTD. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41794053 | Result | Banerji A, Craig T, Sitz K, Li HH, Lumry W, Adatia A, Yang W, Jacobs JS, Tachdjian R, Soong W, Manning M, Wedner J, Savic S, Manson A, Valerieva A, Gunsior M, Mugundu G, Cohen T, Bernard K, VanEenwyk C, Joseph K, Best JM, Morabito C, Riedl MA. Open-label phase 1b/2 trial of navenibart, a long-acting plasma kallikrein inhibitor for hereditary angioedema. J Allergy Clin Immunol. 2026 May;157(5):1127-1135.e6. doi: 10.1016/j.jaci.2026.02.034. Epub 2026 Mar 5. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Single Dose Navenibart | Participants received 1 dose (450 milligrams [mg]) of navenibart. |
| FG001 | Cohort 2: Multiple Dose Navenibart | Participants received 2 doses (600 mg, 300 mg) of navenibart administered 3 months apart. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 10, 2023 | Mar 4, 2026 |
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|
| 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). | 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). | 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). | 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). | 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. | 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). | 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). | 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. | 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. | 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) |
| Scottsdale |
| Arizona |
| 85251 |
| United States |
| Allergy & Asthma Clinic of Northwest Arkansas | Bentonville | Arkansas | 72712 | United States |
| Acuro Research, Inc. | Little Rock | Arkansas | 72205 | United States |
| UC San Diego US HAEA Angioedema Center | San Diego | California | 92122 | United States |
| Raffi Tachdjian MD, Inc | Santa Monica | California | 90404 | United States |
| Allergy & Asthma Clinical Research | Walnut Creek | California | 94598 | United States |
| Institute for Asthma and Allergy, PC | Chevy Chase | Maryland | 20815 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Optimed Research | Columbus | Ohio | 43235 | United States |
| Penn State Health Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| AARA Research Center | Dallas | Texas | 75231 | United States |
| Diagnostical Consultative Center Convex Ltd. | Sofia | 1680 | Bulgaria |
| University of Alberta | Edmonton | Alberta | T6G 2R3 | Canada |
| Ottawa Allergy Research Corporation | Ottawa | Ontario | K1H 1E4 | Canada |
| Institute of Clinical Immunology/Allergology, Faculty Hospital | Hradec Králové | 500 05 | Czechia |
| Charité Universitätsmedizin Berlin | Berlin | 12203 | Germany |
| Addenbrooke's Hospital | Cambridge | CB2 0QQ | United Kingdom |
| St. James's Hospital | Leeds | LS9 7TF | United Kingdom |
| FG002 | Cohort 3: Multiple Dose Navenibart | Participants received 2 doses (600 mg) of navenibart administered 1 month apart. |
| Received at Least 1 Dose of Study Drug | Safety Analysis Set |
|
| COMPLETED |
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| NOT COMPLETED |
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Safety Analysis Set: all participants who received any amount of navenibart.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Single Dose Navenibart | Participants received 1 dose (450 mg) of navenibart. |
| BG001 | Cohort 2: Multiple Dose Navenibart | Participants received 2 doses (600 mg, 300 mg) of navenibart administered 3 months apart. |
| BG002 | Cohort 3: Multiple Dose Navenibart | Participants received 2 doses (600 mg) of navenibart administered 1 month apart. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Safety Analysis Set: all participants who received any amount of navenibart. | Posted | Count of Participants | Participants | Day 1 through Day 448 (Cohort 1), Day 531 (Cohort 2), Day 475 (Cohort 3) |
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| Secondary | 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. | Efficacy Analysis Set: all participants who received any amount of navenibart and had 1 post-baseline assessment of HAE attack. | Posted | Mean | Standard Deviation | % change in monthly HAE attack rate | Baseline, Day 168 (Cohort 1), Day 251 (Cohort 2), Day 195 (Cohort 3) |
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| Secondary | 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). | Efficacy Analysis Set: all participants who received any amount of navenibart and had 1 post-baseline assessment of HAE attack. | Posted | Count of Participants | Participants | Baseline through Day 168 (Cohort 1), Day 251 (Cohort 2), Day 195 (Cohort 3) |
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| Secondary | 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). | Efficacy Analysis Set: all participants who received any amount of navenibart and had 1 post-baseline assessment of HAE attack. | Posted | Count of Participants | Participants | Day 1 through Day 168 (Cohort 1), Day 251 (Cohort 2), and Day 195 (Cohort 3) |
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| Secondary | 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). | Efficacy Analysis Set: all participants who received any amount of navenibart and had 1 post-baseline assessment of HAE attack. Here, 'Overall Number of Participants Analyzed' signifies those participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | hours | Day 1 through Day 168 (Cohort 1), Day 251 (Cohort 2), and Day 195 (Cohort 3) |
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| Secondary | 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). | Efficacy Analysis Set: all participants who received any amount of navenibart and had 1 post-baseline assessment of HAE attack. | Posted | Mean | Standard Deviation | HAE attacks | Day 1 through Day 168 (Cohort 1), Day 251 (Cohort 2), and Day 195 (Cohort 3) |
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| Secondary | 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. | Efficacy Analysis Set: all participants who received any amount of navenibart and had 1 post-baseline assessment of HAE attack. | Posted | Median | 95% Confidence Interval | days | Day 1 through Day 168 (Cohort 1), Day 251 (Cohort 2), and Day 195 (Cohort 3) |
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| Secondary | 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). | Efficacy Analysis Set: all participants who received any amount of navenibart and had 1 post-baseline assessment of HAE attack. | Posted | Mean | Standard Deviation | proportion of HAE attack-free days | Day 1 through Day 168 (Cohort 1), Day 251 (Cohort 2), and Day 195 (Cohort 3) |
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| Secondary | 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). | Pharmacokinetics Analysis Set: all participants who received navenibart and had at least 1 concentration post-dose sample available to enable assessment of pharmacokinetics. | Posted | Geometric Mean | Geometric Coefficient of Variation | mcg/mL | 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) |
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| Secondary | 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. | Pharmacodynamics Analysis Set: all participants who received at least 1 dose of navenibart and had pharmacodynamics assessments at baseline and at least 1 post-baseline visit assessment. Here, 'Overall Number of Participants Analyzed' signifies those participants evaluable for this outcome measure at the specified timepoints. | Posted | Mean | Standard Deviation | percent change from baseline of %cHMWK | Baseline, Day 56 (Cohort 1), Day 90 (Cohort 2), Day 41 (Cohort 3) |
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| Secondary | 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. | Safety Analysis Set: all participants who received any amount of navenibart. Here, 'Overall Number of Participants Analyzed' signifies those participants with baseline and at least 1 post-baseline ADA result. | Posted | Count of Participants | Participants | 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) |
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Day 1 through Day 448 (Cohort 1), Day 531 (Cohort 2), Day 475 (Cohort 3)
Reported safety data based upon Safety Analysis Set: all participants who received any amount of navenibart.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: Single Dose Navenibart | Participants received 1 dose (450 mg) of navenibart. | 0 | 4 | 0 | 4 | 4 | 4 |
| EG001 | Cohort 2: Multiple Dose Navenibart | Participants received 2 doses (600 mg, 300 mg) of navenibart administered 3 months apart. | 0 | 13 | 0 | 13 | 9 | 13 |
| EG002 | Cohort 3: Multiple Dose Navenibart | Participants received 2 doses (600 mg) of navenibart administered 1 month apart. | 0 | 12 | 0 | 12 | 12 | 12 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Eye infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Hyperaesthesia teeth | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Mouth ulceration | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Tongue geographic | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
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| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
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| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
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| Tooth injury | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Osteitis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA 26.0 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 26.0 | Systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA 26.0 | Systematic Assessment |
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| Injection site rash | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Erythema marginatum | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Eustachian tube dysfunction | Ear and labyrinth disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Retinal tear | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
|
Publication by any study site of any data from this study must be carried out in accordance with the clinical trial agreement and not without prior consent of Astria.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Astria Therapeutics Medical Affairs | Astria Therapeutics, Inc. | 1-617-349-1971 | 201study_general@astriatx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 9, 2024 | Mar 4, 2026 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D054179 | Angioedemas, Hereditary |
| D000799 | Angioedema |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000081208 | Hereditary Complement Deficiency Diseases |
| D000081207 | Primary Immunodeficiency Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D007153 | Immunologic Deficiency Syndromes |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Participants received 2 doses (600 mg) of navenibart administered 1 month apart.
|
|
|
|
| Cohort 3: Multiple Dose Navenibart |
Participants received 2 doses (600 mg) of navenibart administered 1 month apart. |
|
|
|
|
|
|
Participants received 2 doses (600 mg) of navenibart administered 1 month apart. |
|
|
Participants received 2 doses (600 mg) of navenibart administered 1 month apart.
|
|
| Units | Counts |
|---|
| Participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
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