Safety and Tolerability Study of Xisomab 3G3 in Healthy Adult Subjects
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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: NCT03097341 |
Recruitment Status :
Completed
First Posted : March 31, 2017
Results First Posted : May 20, 2019
Last Update Posted : June 5, 2019
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Sponsor:
Aronora, Inc.
Information provided by (Responsible Party):
Aronora, Inc.
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention |
Condition |
Thrombosis |
Interventions |
Drug: xisomab 3G3- Dose 1 Drug: xisomab 3G3-Dose 2 Drug: xisomab 3G3-Dose 3 Drug: xisomab 3G3- Dose 4 Other: Placebo |
Enrollment | 21 |
Participant Flow
Recruitment Details | |
Pre-assignment Details | A total of 105 participants were screened for the study, of which 84 did not meet eligibility criteria or declined to participate. The remaining 21 participants were randomized into the study, with each dose level occurring in sequential order. |
Arm/Group Title | Xisomab 3G3- Dose 1 | Xisomab 3G3- Dose 2 | Xisomab 3G3- Dose 3 | Xisomab 3G3- Dose 4 | Placebo |
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Participants received a single intravenous dose of 0.1 mg/kg xisomab 3G3. | Participants received a single intravenous dose of 0.5 mg/kg xisomab 3G3. | Participants received a single intravenous dose of 2.0 mg/kg xisomab 3G3. | Participants received a single intravenous dose of 5.0 mg/kg xisomab 3G3. | 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 |
Baseline Characteristics
Arm/Group Title | Xisomab 3G3- Dose 1 | Xisomab 3G3- Dose 2 | Xisomab 3G3- Dose 3 | Xisomab 3G3- Dose 4 | Placebo | Total | |
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Participants received a single intravenous dose of 0.1 mg/kg xisomab 3G3. | Participants received a single intravenous dose of 0.5 mg/kg xisomab 3G3. | Participants received a single intravenous dose of 2.0 mg/kg xisomab 3G3. | Participants received a single intravenous dose of 5.0 mg/kg xisomab 3G3. | Participants received a single intravenous dose of placebo. | Total of all reporting groups | |
Overall Number of Baseline Participants | 4 | 4 | 4 | 4 | 5 | 21 | |
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[Not Specified]
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Age, Continuous
Mean (Full Range) Unit of measure: Years |
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Number Analyzed | 4 participants | 4 participants | 4 participants | 4 participants | 5 participants | 21 participants | |
42.3
(37 to 47)
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33.0
(25 to 46)
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32.0
(22 to 42)
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42.0
(40 to 45)
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32.2
(25 to 42)
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36.1
(22 to 47)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 4 participants | 4 participants | 4 participants | 4 participants | 5 participants | 21 participants | |
Female |
3 75.0%
|
2 50.0%
|
1 25.0%
|
1 25.0%
|
2 40.0%
|
9 42.9%
|
|
Male |
1 25.0%
|
2 50.0%
|
3 75.0%
|
3 75.0%
|
3 60.0%
|
12 57.1%
|
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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 |
4 100.0%
|
3 75.0%
|
3 75.0%
|
3 75.0%
|
4 80.0%
|
17 81.0%
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|
Not Hispanic or Latino |
0 0.0%
|
1 25.0%
|
1 25.0%
|
1 25.0%
|
1 20.0%
|
4 19.0%
|
|
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 |
0 0.0%
|
0 0.0%
|
0 0.0%
|
1 25.0%
|
0 0.0%
|
1 4.8%
|
|
White |
4 100.0%
|
3 75.0%
|
4 100.0%
|
3 75.0%
|
5 100.0%
|
19 90.5%
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|
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%
|
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 4 participants | 4 participants | 4 participants | 4 participants | 5 participants | 21 participants |
4 | 4 | 4 | 4 | 5 | 21 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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 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.
Results Point of Contact
Name/Title: | Christina U. Lorentz, PhD, Senior Scientist and Project Manager |
Organization: | Aronora, Inc. |
Phone: | 503-964-0250 |
EMail: | christina.lorentz@aronorabio.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Aronora, Inc. |
ClinicalTrials.gov Identifier: | NCT03097341 |
Other Study ID Numbers: |
3G3-15-01 |
First Submitted: | March 21, 2017 |
First Posted: | March 31, 2017 |
Results First Submitted: | February 15, 2019 |
Results First Posted: | May 20, 2019 |
Last Update Posted: | June 5, 2019 |