A Study of SYNT001 in Healthy Volunteers

A Phase 1a, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study of SYNT001 in Healthy Volunteers

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03643627

Enrollment

Registered

2018-08-23

Start date

2016-08-17

Completion date

2017-04-13

Last updated

2018-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGSYNT001

single IV infusion

DRUGPlacebo

single IV infusion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026