A Study of SYNT001 in Healthy Volunteers

Early Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: SYNT001

• Registration Number: NCT03643627
• Lead Sponsor: Syntimmune, Inc.

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 available

Study Timeline

• Study Start: 2016-08-17
• Primary Completion: 2017-04-13
• Study Completion: 2017-04-13
• Status Verified: 2018-08
• Study First Submitted: 2018-08-21
• Study First Submitted QC: 2018-08-21
• Study First Posted: 2018-08-23
• Last Update Submitted: 2018-08-23
• Last Update Posted: 2018-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 31

Inclusion 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
1 mg/kg	SYNT001	-
3 mg/kg	SYNT001	-
10 mg/kg	SYNT001	-
30 mg/kg	SYNT001	-

Primary Outcome Measures

Name	Time	Method
assessment of safety data (counts and percentages of adverse events)	Day 0 - Day 28	counts and percentages of adverse events

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinical Pharmacology of Miami; 🇺🇸 Miami, Florida, United States