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Safety and Tolerability Study of E-WE Thrombin in Healthy Adult Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03453060
Recruitment Status : Completed
First Posted : March 5, 2018
Results First Posted : October 29, 2019
Last Update Posted : October 29, 2019
Sponsor:
Information provided by (Responsible Party):
Aronora, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Sequential Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Thrombosis
Interventions Drug: E-WE Thrombin- Dose 1
Drug: E-WE Thrombin- Dose 2
Drug: E-WE Thrombin- Dose 3
Drug: E-WE Thrombin- Dose 4
Other: Placebo
Enrollment 21
Recruitment Details  
Pre-assignment Details A total of 132 participants were screened for the study, of which 111 did not meet eligibility criteria, declined to participate, or were dropped alternates. The remaining 21 participants were randomized into the study, with each dose level occurring in sequential order.
Arm/Group Title E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Hide Arm/Group Description Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin. Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin. Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin. Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin. Participants received a single intravenous dose of placebo.
Period Title: Overall Study
Started 4 4 4 4 5
Completed 4 4 4 4 5
Not Completed 0 0 0 0 0
Arm/Group Title E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo Total
Hide Arm/Group Description Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin. Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin. Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin. Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin. Participants received a single intravenous dose of placebo. Total of all reporting groups
Overall Number of Baseline Participants 4 4 4 4 5 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 4 participants 4 participants 4 participants 4 participants 5 participants 21 participants
44.0
(40 to 52)
37.3
(26 to 47)
33.8
(23 to 46)
36.0
(23 to 52)
43.0
(33 to 53)
39.0
(23 to 53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 4 participants 4 participants 5 participants 21 participants
Female
3
  75.0%
2
  50.0%
2
  50.0%
3
  75.0%
4
  80.0%
14
  66.7%
Male
1
  25.0%
2
  50.0%
2
  50.0%
1
  25.0%
1
  20.0%
7
  33.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 4 participants 4 participants 5 participants 21 participants
Hispanic or Latino
3
  75.0%
4
 100.0%
2
  50.0%
3
  75.0%
4
  80.0%
16
  76.2%
Not Hispanic or Latino
1
  25.0%
0
   0.0%
2
  50.0%
1
  25.0%
1
  20.0%
5
  23.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 4 participants 4 participants 5 participants 21 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  25.0%
0
   0.0%
1
  25.0%
0
   0.0%
0
   0.0%
2
   9.5%
White
3
  75.0%
3
  75.0%
3
  75.0%
4
 100.0%
5
 100.0%
18
  85.7%
More than one race
0
   0.0%
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 4 participants 4 participants 4 participants 5 participants 21 participants
4 4 4 4 5 21
1.Primary Outcome
Title The Number of Subjects With Treatment-emergent Adverse Events (TEAEs) Will be Summarized Using Frequency Counts.
Hide Description 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.
Time Frame one month
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
3
  75.0%
1
  20.0%
2.Primary Outcome
Title The Number of Subjects With Clinically Significant Changes in Body Temperature, Frequency, and Relation to Treatment Will be Assessed.
Hide Description Body temperature will be measured in degrees Celsius. Clinically significant changes in body temperature are determined by the PI or designee.
Time Frame two days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3.Primary Outcome
Title The Number of Subjects With Clinically Significant Changes in Respiratory Rate, Frequency, and Relation to Treatment Will be Assessed.
Hide Description Respiratory rate will be measured in breaths per minute. Clinically significant changes in respiratory rate are determined by the PI.
Time Frame two days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4.Primary Outcome
Title The Number of Subjects With Clinically Significant Changes in Blood Pressure (Systolic and Diastolic), Frequency, and Relation to Treatment Will be Assessed.
Hide Description 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.
Time Frame two days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
5.Primary Outcome
Title The Number of Subjects With Clinically Significant Changes in Heart Rate, Frequency, and Relation to Treatment Will be Assessed.
Hide Description Heart rate will be measured in beats per minute. Clinically significant changes in heart rate are determined by the PI or designee.
Time Frame two days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
6.Primary Outcome
Title The Number of Subjects With Abnormal Electrocardiogram and Frequency and/ or Adverse Events That Are Related to Treatment.
Hide Description 12-lead electrocardiogram measurement. Abnormal electrocardiograms are determined by the PI or designee.
Time Frame two days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
7.Primary Outcome
Title 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.
Hide Description Plasma aPTT will be measured in seconds. Clinically significant changes in aPTT are determined by the PI or designee.
Time Frame one month
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
8.Primary Outcome
Title 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.
Hide Description Prothrombin time will be measured in seconds. Clinically significant changes in prothrombin time are determined by the PI or designee.
Time Frame one month
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
9.Primary Outcome
Title 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.
Hide Description Thrombin time will be measured in seconds. Clinically significant changes in thrombin time are determined by the PI or designee.
Time Frame one month
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
10.Primary Outcome
Title 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.
Hide Description Plasma fibrinogen levels will be measured in mg/dL. Clinically significant changes in plasma fibrinogen levels are determined by the PI or designee.
Time Frame one month
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
11.Primary Outcome
Title The Number of Subjects With Injection Site Reaction and/ or Adverse Events That Are Related to Treatment.
Hide Description Injection site reaction assessment (pain, tenderness, erythema/ redness, and induration/ swelling.
Time Frame two days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
12.Primary Outcome
Title The Number of Subjects That Develop Treatment-related Immunogenicity.
Hide Description Immunogenicity measured by plasma anti-drug antibodies.
Time Frame one month
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
13.Primary Outcome
Title The Number of Subjects With Clinically Significant Changes in Blood Urea Nitrogen Levels (BUN) as Part of a Standard Serum Chemistry Panel, Frequency, and Relation to Treatment Will be Assessed.
Hide Description BUN levels in the blood will be measured in mg/dL. Clinically significant changes in BUN are determined by the PI or designee.
Time Frame two days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
14.Primary Outcome
Title The Number of Subjects With Clinically Significant Changes in Bilirubin (Total and Direct) Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.
Hide Description Bilirubin (total and direct) levels in the blood will be measured in mg/dL. Clinically significant changes in total and direct bilirubin levels are determined by the PI or designee.
Time Frame two days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
15.Primary Outcome
Title The Number of Subjects With Clinically Significant Changes in Alkaline Phosphatase Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.
Hide Description Alkaline phosphatase levels in the blood will be measured in U/L. Clinically significant changes in alkaline phosphatase levels are determined by the PI or designee.
Time Frame two days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
16.Primary Outcome
Title The Number of Subjects With Clinically Significant Changes in Aspartate Aminotransferase (AST) Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.
Hide Description AST levels in the blood will be measured in U/L. Clinically significant changes in AST levels are determined by the PI or designee.
Time Frame two days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
17.Primary Outcome
Title The Number of Subjects With Clinically Significant Changes in Alanine Aminotransferase (ALT) Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.
Hide Description ALT levels in the blood will be measured in U/L. Clinically significant changes in ALT levels are determined by the PI or designee.
Time Frame two days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
18.Primary Outcome
Title The Number of Subjects With Clinically Significant Changes in Lactate Dehydrogenase (LDH) Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.
Hide Description LDH levels in the blood will be measured in U/L. Clinically significant changes in LDH levels are determined by the PI or designee.
Time Frame two days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
19.Primary Outcome
Title The Number of Subjects With Clinically Significant Changes in Albumin Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.
Hide Description Albumin levels in the blood will be measured in g/dL. Clinically significant changes in albumin levels are determined by the PI or designee.
Time Frame two days.
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
20.Primary Outcome
Title The Number of Subjects With Clinically Significant Changes in Sodium Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.
Hide Description Sodium levels will be measured in mEq/L. Clinically significant changes in sodium levels are determined by the PI or designee.
Time Frame two days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
21.Primary Outcome
Title The Number of Subjects With Clinically Significant Changes in Potassium Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.
Hide Description Potassium levels will be measured in mEq/L. Clinically significant changes in potassium levels are determined by the PI or designee.
Time Frame two days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
22.Primary Outcome
Title The Number of Subjects With Clinically Significant Changes in Chloride Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.
Hide Description Chloride levels will be measured in mEq/L. Clinically significant changes in chloride levels are determined by the PI or designee.
Time Frame two days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
23.Primary Outcome
Title The Number of Subjects With Clinically Significant Changes in Bicarbonate Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.
Hide Description Bicarbonate levels will be measured in mEq/L. Clinically significant changes in bicarbonate levels are determined by the PI or designee.
Time Frame two days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
24.Primary Outcome
Title The Number of Subjects With Clinically Significant Changes in Glucose Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.
Hide Description Blood glucose levels will be measured in mg/dL. Clinically significant changes in blood glucose levels are determined by the PI or designee.
Time Frame two days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
25.Primary Outcome
Title The Number of Subjects With Clinically Significant Changes in Creatinine Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.
Hide Description Creatinine levels will be measured in mg/dL. Clinically significant changes in creatinine levels are determined by the PI or designee.
Time Frame two days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
26.Primary Outcome
Title The Number of Subjects With Clinically Significant Changes in Hemoglobin Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Hematology Panel.
Hide Description Hemoglobin levels will be measured in g/dL. Clinically significant changes in hemoglobin levels are determined by the PI or designee.
Time Frame two days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
27.Primary Outcome
Title The Number of Subjects With Clinically Significant Changes in Hematocrit Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Hematology Panel.
Hide Description Hematocrit levels will be measured in %. Clinically significant changes in hematocrit levels are determined by the PI or designee.
Time Frame two days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
28.Primary Outcome
Title The Number of Subjects With Clinically Significant Changes in Total Leukocyte Counts, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Hematology Panel.
Hide Description Total leukocyte counts will be measured in 10˄3/uL. Clinically significant changes in leukocyte counts are determined by the PI or designee.
Time Frame two days.
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
29.Primary Outcome
Title The Number of Subjects With Clinically Significant Changes in Differential Leukocyte Counts, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Hematology Panel.
Hide Description Differential leukocyte counts will be measured in %. Clinically significant changes in differential leukocyte counts are determined by the PI or designee.
Time Frame two days.
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
30.Primary Outcome
Title The Number of Subjects With Clinically Significant Changes in Red Blood Cell Count, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Hematology Panel.
Hide Description Red blood cell count will be measured in 10˄6/uL. Clinically significant changes in red blood cell counts are determined by the PI or designee.
Time Frame two days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
31.Primary Outcome
Title The Number of Subjects With Clinically Significant Changes in Platelet Count, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Hematology Panel.
Hide Description Platelet count will be measured in 10˄3/uL. Clinically significant changes in platelet counts are determined by the PI or designee.
Time Frame two days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
32.Primary Outcome
Title The Number of Subjects With Clinically Significant Changes in Urine pH, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel.
Hide Description pH of the urine will be measured. Clinically significant changes in urine pH are determined by the PI or designee.
Time Frame two days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
33.Primary Outcome
Title The Number of Subjects With Clinically Significant Changes in Urine Specific Gravity, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel.
Hide Description Specific gravity of the urine will be evaluated. Clinically significant changes in specific gravity are determined by the PI or designee.
Time Frame two days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
34.Primary Outcome
Title The Number of Subjects With Clinically Significant Changes in Urine Protein Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel.
Hide Description Protein levels in the urine will be evaluated. Clinically significant changes in protein levels are determined by the PI or designee.
Time Frame two days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
35.Primary Outcome
Title The Number of Subjects With Clinically Significant Changes in Urine Glucose Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel.
Hide Description Glucose levels in the urine will be evaluated. Clinically significant changes in urine glucose are determined by the PI or designee.
Time Frame two days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
36.Primary Outcome
Title The Number of Subjects With Clinically Significant Changes in Urine Ketone Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel.
Hide Description Ketone levels in the urine will be evaluated. Clinically significant changes in urine ketone levels are determined by the PI or designee.
Time Frame two days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
37.Primary Outcome
Title The Number of Subjects With Clinically Significant Changes in Urine Bilirubin Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel.
Hide Description Bilirubin levels in the urine will be evaluated. Clinically significant changes in urine bilirubin levels are determined by the PI or designee.
Time Frame two days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
38.Primary Outcome
Title The Number of Subjects With Clinically Significant Changes in Urine Blood Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel.
Hide Description Blood levels in the urine will be evaluated. Clinically significant changes in urine blood levels are determined by the PI or designee.
Time Frame two days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
39.Primary Outcome
Title The Number of Subjects With Clinically Significant Changes in Urine Nitrite Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel.
Hide Description Nitrite levels in the urine will be evaluated. Clinically significant changes in urine nitrite levels are determined by the PI or designee.
Time Frame two days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
40.Primary Outcome
Title The Number of Subjects With Clinically Significant Changes in Urine Urobilinogen Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel.
Hide Description Urobilinogen levels in the urine will be evaluated. Clinically significant changes in urine urobilinogen levels are determined by the PI or designee.
Time Frame two days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
41.Primary Outcome
Title The Number of Subjects With Clinically Significant Changes in Urine Leukocyte Esterase Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel.
Hide Description Leukocyte esterase levels in the urine will be evaluated. Clinically significant changes in urine leukocyte esterase levels are determined by the PI or designee.
Time Frame two days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
42.Secondary Outcome
Title The Effect of a Single Intravenous Dose of E-WE Thrombin on Generation of Activated Protein C- Protein C Inhibitor Complexes (APC-PCI).
Hide Description Plasma APC-PCI levels will be measured in ng/mL.
Time Frame Predose, 0.08, 0.25, 0.5, 1, 2, 4, and 24h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Mean (Standard Deviation)
Unit of Measure: ng/mL
predose 1.8  (0.9) 1.3  (0.7) 2.0  (0.7) 1.0  (0.0) 1.5  (0.7)
0.08 hours post dose 61.8  (16.3) 123.0  (5.0) 195.3  (16.8) 283.3  (61.2) 1.7  (0.9)
0.25 hours post dose 108.2  (20.5) 218.3  (4.6) 364.8  (86.4) 579.0  (82.0) 1.2  (0.5)
0.5 hours post dose 122.0  (18.6) 229.8  (19.4) 470.8  (140.9) 678.3  (84.8) 1.3  (0.6)
1 hour post dose 90.9  (12.9) 194.5  (24.2) 328.8  (94.0) 480.5  (33.6) 1.2  (0.5)
2 hours post dose 27.3  (3.8) 56.2  (14.8) 124.5  (40.4) 132.3  (17.4) 1.2  (0.5)
4 hours post dose 3.5  (0.5) 5.9  (1.3) 12.7  (6.2) 15.2  (4.3) 1.0  (0.0)
24 hours post dose 1.0  (0.0) 1.0  (0.0) 1.7  (0.9) 1.0  (0.0) 1.6  (0.8)
Time Frame Adverse events were recorded from subject check-in through follow up which occurred on Day 28.
Adverse Event Reporting Description Subjects were monitored throughout confinement for adverse reactions to the study drug and/or procedures. Subjects were asked how they are feeling and were encouraged to report AEs during confinement and at each follow-up visit.
 
Arm/Group Title E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Hide Arm/Group Description Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin. Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin. Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin. Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin. Participants received a single intravenous dose of placebo.
All-Cause Mortality
E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)      0/4 (0.00%)      0/4 (0.00%)      0/4 (0.00%)      0/5 (0.00%)    
Hide Serious Adverse Events
E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      0/4 (0.00%)      0/4 (0.00%)      0/4 (0.00%)      0/5 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
E-WE Thrombin Dose 1 E-WE Thrombin Dose 2 E-WE Thrombin Dose 3 E-WE Thrombin Dose 4 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      0/4 (0.00%)      0/4 (0.00%)      3/4 (75.00%)      1/5 (20.00%)    
General disorders           
Vessel puncture site haemorrhage † 1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/5 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Back pain † 1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/5 (20.00%)  1
Nervous system disorders           
Headache † 1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 2/4 (50.00%)  2 0/5 (0.00%)  0
Psychiatric disorders           
Insomnia † 1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/5 (0.00%)  0
Skin and subcutaneous tissue disorders           
Pruritus † 1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/5 (20.00%)  1
Rash papular † 1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/5 (20.00%)  1
Skin exfoliation † 1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/5 (20.00%)  1
1
Term from vocabulary, MedDRA (21.0)
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Aronora, Inc. shall retain title to and the right to publish all documentation, records, raw data, specimens, or other work product generated in connection with this study. Such publications shall not be made by the PI or Celerion without the prior written consent of Aronora, Inc.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Norah G. Verbout, Senior Scientist and Project Manager
Organization: Aronora, Inc.
Phone: 503-964-0250
EMail: norah.verbout@aronorabio.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Aronora, Inc.
ClinicalTrials.gov Identifier: NCT03453060    
Other Study ID Numbers: EWE-17-01
First Submitted: February 20, 2018
First Posted: March 5, 2018
Results First Submitted: October 3, 2019
Results First Posted: October 29, 2019
Last Update Posted: October 29, 2019