Adults 18 to 55, any sex, with Thrombosis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The Number of Subjects With Treatment-emergent Adverse Events (TEAEs) Will be Summarized Using Frequency Counts.Primary· one month
TEAEs will be determined by symptom driven physical examinations that can include assessment of the skin, head, ears, eyes, nose, throat, respiratory system, cardiovascular system, gastrointestinal system, neurological condition, blood and lymphatic systems, and the musculoskeletal system.
Group
Value
95% CI
E-WE Thrombin Dose 1
0
E-WE Thrombin Dose 2
0
E-WE Thrombin Dose 3
0
E-WE Thrombin Dose 4
3
Placebo
1
The Number of Subjects With Clinically Significant Changes in Body Temperature, Frequency, and Relation to Treatment Will be Assessed.Primary· two days
Body temperature will be measured in degrees Celsius. Clinically significant changes in body temperature are determined by the PI or designee.
Group
Value
95% CI
E-WE Thrombin Dose 1
0
E-WE Thrombin Dose 2
0
E-WE Thrombin Dose 3
0
E-WE Thrombin Dose 4
0
Placebo
0
The Number of Subjects With Clinically Significant Changes in Respiratory Rate, Frequency, and Relation to Treatment Will be Assessed.Primary· two days
Respiratory rate will be measured in breaths per minute. Clinically significant changes in respiratory rate are determined by the PI.
Group
Value
95% CI
E-WE Thrombin Dose 1
0
E-WE Thrombin Dose 2
0
E-WE Thrombin Dose 3
0
E-WE Thrombin Dose 4
0
Placebo
0
The Number of Subjects With Clinically Significant Changes in Blood Pressure (Systolic and Diastolic), Frequency, and Relation to Treatment Will be Assessed.Primary· two days
Systolic and diastolic blood pressure will be measured in mmHg. Clinically significant changes in systolic and diastolic blood pressure are determined by the PI or designee.
Group
Value
95% CI
E-WE Thrombin Dose 1
0
E-WE Thrombin Dose 2
0
E-WE Thrombin Dose 3
0
E-WE Thrombin Dose 4
0
Placebo
0
The Number of Subjects With Clinically Significant Changes in Heart Rate, Frequency, and Relation to Treatment Will be Assessed.Primary· two days
Heart rate will be measured in beats per minute. Clinically significant changes in heart rate are determined by the PI or designee.
Group
Value
95% CI
E-WE Thrombin Dose 1
0
E-WE Thrombin Dose 2
0
E-WE Thrombin Dose 3
0
E-WE Thrombin Dose 4
0
Placebo
0
The Number of Subjects With Abnormal Electrocardiogram and Frequency and/ or Adverse Events That Are Related to Treatment.Primary· two days
12-lead electrocardiogram measurement. Abnormal electrocardiograms are determined by the PI or designee.
Group
Value
95% CI
E-WE Thrombin Dose 1
0
E-WE Thrombin Dose 2
0
E-WE Thrombin Dose 3
0
E-WE Thrombin Dose 4
0
Placebo
0
The Number of Subjects With Clinically Significant Changes in Activated Partial Thromboplastin Time (aPTT), Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Coagulation Panel.Primary· one month
Plasma aPTT will be measured in seconds. Clinically significant changes in aPTT are determined by the PI or designee.
Group
Value
95% CI
E-WE Thrombin Dose 1
0
E-WE Thrombin Dose 2
0
E-WE Thrombin Dose 3
0
E-WE Thrombin Dose 4
0
Placebo
0
The Number of Subjects With Clinically Significant Changes in Prothrombin Time, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Coagulation Panel.Primary· one month
Prothrombin time will be measured in seconds. Clinically significant changes in prothrombin time are determined by the PI or designee.
Group
Value
95% CI
E-WE Thrombin Dose 1
0
E-WE Thrombin Dose 2
0
E-WE Thrombin Dose 3
0
E-WE Thrombin Dose 4
0
Placebo
0
The Number of Subjects With Clinically Significant Changes in Thrombin Time, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Coagulation Panel.Primary· one month
Thrombin time will be measured in seconds. Clinically significant changes in thrombin time are determined by the PI or designee.
Group
Value
95% CI
E-WE Thrombin Dose 1
0
E-WE Thrombin Dose 2
0
E-WE Thrombin Dose 3
0
E-WE Thrombin Dose 4
0
Placebo
0
The Number of Subjects With Clinically Significant Changes in Plasma Fibrinogen, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Coagulation Panel.Primary· one month
Plasma fibrinogen levels will be measured in mg/dL. Clinically significant changes in plasma fibrinogen levels are determined by the PI or designee.
Group
Value
95% CI
E-WE Thrombin Dose 1
0
E-WE Thrombin Dose 2
0
E-WE Thrombin Dose 3
0
E-WE Thrombin Dose 4
0
Placebo
0
The Number of Subjects With Injection Site Reaction and/ or Adverse Events That Are Related to Treatment.Primary· two days
Injection site reaction assessment (pain, tenderness, erythema/ redness, and induration/ swelling.
Group
Value
95% CI
E-WE Thrombin Dose 1
0
E-WE Thrombin Dose 2
0
E-WE Thrombin Dose 3
0
E-WE Thrombin Dose 4
0
Placebo
0
The Number of Subjects That Develop Treatment-related Immunogenicity.Primary· one month
Immunogenicity measured by plasma anti-drug antibodies.
Group
Value
95% CI
E-WE Thrombin Dose 1
0
E-WE Thrombin Dose 2
0
E-WE Thrombin Dose 3
0
E-WE Thrombin Dose 4
0
Placebo
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were recorded from subject check-in through follow up which occurred on Day 28..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Aronora, Inc.
Last refreshed: 29 October 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03453060.