A Study of SYNT001 in Healthy Volunteers | NCT03643627

Studies
A Study of SYNT001 in Healthy Volunteers

NCT03643627

Sponsor

Syntimmune, Inc.

Status

Completed

Last Update Posted

Aug 24, 2018Actual

Enrollment

31Actual

Phase

Early Phase 1

Conditions

Healthy

Interventions

SYNT001
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 17, 2016Actual

Primary Completion Date

Apr 13, 2017Actual

Completion Date

Apr 13, 2017Actual

First Submitted Date

Aug 21, 2018

First Submission Date that Met QC Criteria

Aug 21, 2018

First Posted Date

Aug 23, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 23, 2018

Last Update Posted Date

Aug 24, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Placebo	Placebo Comparator	Drug: Placebo
1 mg/kg	Experimental	Drug: SYNT001
3 mg/kg	Experimental	Drug: SYNT001
10 mg/kg	Experimental	Drug: SYNT001
30 mg/kg	Experimental	Drug: SYNT001

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SYNT001	Drug	single IV infusion	1 mg/kg 10 mg/kg 3 mg/kg 30 mg/kg

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Pharmacology of Miami		Miami	Florida	33014	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided