A Study of SYNT001 in Healthy Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: SYNT001

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33014
      • Clinical Pharmacology of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; single IV infusion
Experimental: 1 mg/kg	Drug: SYNT001; single IV infusion
Experimental: 10 mg/kg	Drug: SYNT001; single IV infusion
Experimental: 3 mg/kg	Drug: SYNT001; single IV infusion
Experimental: 30 mg/kg	Drug: SYNT001; single IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assessment of safety data (counts and percentages of adverse events)	counts and percentages of adverse events	Day 0 - Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Pharmacodynamics	total serum IgG levels	Days 1 (pre dose), 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 21 and 28

Collaborators and Investigators

• Sponsor: Syntimmune, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2016
• Primary Completion (Actual): April 13, 2017
• Study Completion (Actual): April 13, 2017

Study Registration Dates

• First Submitted: August 21, 2018
• First Submitted That Met QC Criteria: August 21, 2018
• First Posted (Actual): August 23, 2018

Study Record Updates

• Last Update Posted (Actual): August 24, 2018
• Last Update Submitted That Met QC Criteria: August 23, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: SYNT-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No