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OpenTrials
Completed

NCT Number: NCT03643627

A 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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Clinical Pharmacology of Miami

Miami, Florida, 33014, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SYNT001

Drug

single IV infusion

Placebo

Drug

single IV infusion

Primary outcomes

  1. assessment of safety data (counts and percentages of adverse events)

    Time frame: Day 0 - Day 28

    counts and percentages of adverse events

Secondary outcomes

  1. Pharmacokinetics (serum concentration of SYNT001)

    Time frame: Pre-dose and 0.08, 2, 4, 6, 8, 12, 16, 20, 24, 48, 72, and 120 hours post dose

    serum concentration of SYNT001

  2. Pharmacodynamics

    Time frame: Days 1 (pre dose), 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 21 and 28

    total serum IgG levels

Sponsors and collaborators

Lead sponsor

Syntimmune, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 23, 2018
Registry last updated
Aug 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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