Trial | NCT03643627  Report issue

Title

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

  • Phase

    Early Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    SYNT001 ...

  • Study Participants

    31
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.
Study Started
Aug 17
2016
Primary Completion
Apr 13
2017
Study Completion
Apr 13
2017
Last Update
Aug 24
2018

Drug SYNT001

single IV infusion

Drug Placebo

single IV infusion

Placebo Placebo Comparator

1 mg/kg Experimental

3 mg/kg Experimental

10 mg/kg Experimental

30 mg/kg Experimental

Criteria 

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
No Results Posted