Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
31 participants
INTERVENTIONAL
2016-08-17
2017-04-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
single IV infusion
1 mg/kg
SYNT001
single IV infusion
3 mg/kg
SYNT001
single IV infusion
10 mg/kg
SYNT001
single IV infusion
30 mg/kg
SYNT001
single IV infusion
Interventions
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SYNT001
single IV infusion
Placebo
single IV infusion
Eligibility Criteria
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Inclusion Criteria
* Healthy as determined by comprehensive clinical assessment and clinical laboratory investigations
* Body mass index 18.5 to 30.0 kg/m2
* Must use medically acceptable contraception
* Willingness to complete all study measurements and assessments in compliance with the protocol
Exclusion Criteria
* Past or present disease that is judged by the investigator to have the potential to interfere with the study procedures, compromise safety or affect the PK evaluations
* Subject unable or unwilling to comply with the protocol
* Any exposure to an investigational drug within the 30 days prior to screening
* Use of any tobacco or nicotine-containing products
* Abuse of alcohol
* Positive drug test or history of drug abuse
18 Years
55 Years
MALE
Yes
Sponsors
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Syntimmune, Inc.
INDUSTRY
Responsible Party
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Locations
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Clinical Pharmacology of Miami
Miami, Florida, United States
Countries
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Other Identifiers
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SYNT-101
Identifier Type: -
Identifier Source: org_study_id
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