A Study of SYNT001 in Healthy Volunteers



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:8/26/2018
Start Date:August 17, 2016
End Date:April 13, 2017

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase 1a, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study of SYNT001 in Healthy Volunteers

This study is being done to compare the safety, tolerability, pharmacokinetics (PK),
pharmacodynamics (PD), and immunogenicity of an intravenous (IV) formulation of SYNT001. This
is the first-in-human (FIH) study of SYNT001.


IInclusion Criteria:

Subjects must meet the following criteria to be included:

- 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:

Subjects meeting any of the following criteria are to be excluded:

- 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
We found this trial at
1
site
Clinical Pharmacology of Miami
Miami, Florida 33014
?
mi
from
Miami, FL
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