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NCT04075175 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by MassBiologics.

Completed
Registry status
Phase 1
Development phase
41
Enrollment target

NCT04075175 is a Phase 1 study that has completed, run by MassBiologics. The registered enrollment target is 41 participants.

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The verdict

NCT04075175, a Phase 1 study, has completed, sponsored by MassBiologics.

COMPLETED
Registry status
Phase 1
Development phase
41 participants
Enrollment target

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.

Interventions

  • DRUG S315
  • DRUG 0.9% Sodium Chloride (NaCl)

Trial Details

FieldValue
Enrollment Target 41 participants
Start Date 2019-04-23
Est. Completion 2019-10-07
Phase Phase 1

Sponsor

MassBiologics

6 total trials

What the Registry Record Tells You About NCT04075175

The ClinicalTrials.gov registry entry for NCT04075175 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MassBiologics, which has 6 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which S315 is the first listed.

NCT04075175 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04075175 about?

NCT04075175 is a clinical study titled "Evaluate the Safety Pharmacokinetics of a Human Monoclonal Antibody S315 Against Diphtheria Toxin in Healthy Subjects". 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 ...

What is the current status of trial NCT04075175?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2019-04-23. Estimated completion is 2019-10-07.

What interventions are being tested in trial NCT04075175?

The interventions under investigation include: S315 (DRUG), 0.9% Sodium Chloride (NaCl) (DRUG).

Who is sponsoring clinical trial NCT04075175?

This trial is sponsored by MassBiologics, which has 6 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.