A Study of SYNT001 in Healthy Volunteers
A Phase 1a, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study of SYNT001 in Healthy Volunteers
1 other identifier
interventional
31
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1 healthy
Started Aug 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 13, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 13, 2017
CompletedFirst Submitted
Initial submission to the registry
August 21, 2018
CompletedFirst Posted
Study publicly available on registry
August 23, 2018
CompletedAugust 24, 2018
August 1, 2018
8 months
August 21, 2018
August 23, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
assessment of safety data (counts and percentages of adverse events)
counts and percentages of adverse events
Day 0 - Day 28
Secondary Outcomes (2)
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
Pharmacodynamics
Days 1 (pre dose), 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 21 and 28
Study Arms (5)
Placebo
PLACEBO COMPARATOR1 mg/kg
EXPERIMENTAL3 mg/kg
EXPERIMENTAL10 mg/kg
EXPERIMENTAL30 mg/kg
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Syntimmune, Inc.lead
Study Sites (1)
Clinical Pharmacology of Miami
Miami, Florida, 33014, United States
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2018
First Posted
August 23, 2018
Study Start
August 17, 2016
Primary Completion
April 13, 2017
Study Completion
April 13, 2017
Last Updated
August 24, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share