A Study of SYNT001 in Healthy Volunteers

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03643627
• Other study ID #: SYNT-101
• Status: Completed
• Phase: Early Phase 1
• Start date: August 17, 2016
• Est. completion date: April 13, 2017

Study information

• Verified date: August 2018
• Source: Syntimmune, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: April 13, 2017
• Est. primary completion date: April 13, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• SYNT001
single IV infusion
• Placebo
single IV infusion

Locations

Country	Name	City	State
United States	Clinical Pharmacology of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Syntimmune, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assessment of safety data (counts and percentages of adverse events)	counts and percentages of adverse events	Day 0 - Day 28
Secondary	Pharmacokinetics (serum concentration of SYNT001)	serum concentration of SYNT001	Pre-dose and 0.08, 2, 4, 6, 8, 12, 16, 20, 24, 48, 72, and 120 hours post dose
Secondary	Pharmacodynamics	total serum IgG levels	Days 1 (pre dose), 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 21 and 28