A Study of SYNT001 in Healthy Volunteers

• Sponsor: Syntimmune, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03643627
• Collaborator: (none)
• Enrollment: 31
• Location: 1
• Arms: 5
• Actual Duration (Months): 7.9
• Patients Per Site Per Month: 3.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: SYNT001; Drug: Placebo	Early Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 31 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 1a, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study of SYNT001 in Healthy Volunteers
• Actual Study Start Date: Aug 17, 2016
• Actual Primary Completion Date: Apr 13, 2017
• Actual Study Completion Date: Apr 13, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. assessment of safety data (counts and percentages of adverse events) [Day 0 - Day 28]

   counts and percentages of adverse events

Secondary Outcome Measures

1. Pharmacokinetics (serum concentration of SYNT001) [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 [Days 1 (pre dose), 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 21 and 28]

   total serum IgG levels

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Pharmacology of Miami	Miami	Florida	United States	33014

Sponsors and Collaborators

• Syntimmune, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Syntimmune, Inc.
• ClinicalTrials.gov Identifier: NCT03643627
• Other Study ID Numbers: SYNT-101
• First Posted: Aug 23, 2018
• Last Update Posted: Aug 24, 2018
• Last Verified: Aug 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 24, 2018