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Evaluate the Safety Pharmacokinetics of a Human Monoclonal Antibody S315 Against Diphtheria Toxin in Healthy Subjects

NCT04075175 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2020-02-05

No results posted yet for this study

Summary

This study will examine the use of a single infusion of S315 at different doses in healthy volunteers to help understand its safety and tolerability. S315 is a monoclonal antibody that is being developed for treatment of diphtheria. The study will assess for any side effects when S315 and will also look at the levels of S315 in the blood over time.

Conditions

  • Diphtheria

Interventions

DRUG

S315

Human monoclonal antibody against Diphtheria Toxin

DRUG

0.9% Sodium Chloride (NaCl)

Placebo 0.9% Sodium Chloride (NaCl)

Sponsors & Collaborators

  • MassBiologics

    lead OTHER

Principal Investigators

  • John Z Sullivan-Bólyai, MD, MPH · MassBiologics of the University of Massachusetts

  • Ronald Goldwater, MD · Parexel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-23
Primary Completion
2019-10-07
Completion
2019-10-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04075175 on ClinicalTrials.gov