A Study of SYNT001 in Healthy Volunteers

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT03643627

Run by

Syntimmune, Inc.

People needed

31

Starts

2016-08-17

Expected to finish

2017-04-13

Last updated by the study team

2018-08-24

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may not qualify if…

• 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

Where it is running

• Clinical Pharmacology of Miami — Miami, Florida, United States

Full record on ClinicalTrials.gov

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