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NCT04863287 · ClinicalTrials.gov registry record · Phase 1

First Clinical Study of the Safety and Blood Levels of a Human Monoclonal Antibody (2217LS) Against Lyme Disease Bacteria in Healthy People

A Phase 1 study of Lyme Disease, sponsored by MassBiologics.

Completed
Registry status
Phase 1
Development phase
44
Enrollment target
1
Study location

NCT04863287 is a Phase 1 study of Lyme Disease that has completed, run by MassBiologics. The registered enrollment target is 44 participants, below the 3,869-participant average among 9 other Lyme Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04863287, a Phase 1 study of Lyme Disease, has completed, sponsored by MassBiologics.

COMPLETED
Registry status
Phase 1
Development phase
44 participants
Enrollment target
1
Study location

Study Summary

This is a research study of the investigational drug 2217LS in healthy volunteers. Investigational means 2217LS is a new drug that has not been approved for the treatment of any disease. 2217LS is human antibody designed to provide protection from Lyme disease. Lyme disease is a disease carried by infected ticks and can cause the infection to spread to the joints, heart and nervous system in humans. This is the first time 2217LS will be given to humans. This is not a study of how well 2217LS works against Lyme disease. The only purposes of this study are to: 1) Learn about the safety and tolerability of a subcutaneous (SC \[under the skin\]) injection of 2217LS when administered to healthy volunteers. 2) Find out how much 2217LS is in the blood of healthy volunteers after receiving 2217LS SC. In this study, groups of healthy volunteers will be given different doses of 2217LS by SC injection. Volunteers will stay in the study unit for a total of 4 overnights. The planned duration of participation is up to 14 months. Study personnel will monitor their safety using standard procedures like physical examinations, electrocardiograms, questions about possible side effects, blood and urine tests. The amount of 2217LS in their blood will also be measured.

Conditions Studied

Lyme Disease

Interventions

  • BIOLOGICAL 2217LS
  • OTHER 0.9% Sodium Chloride (NaCl)

Study Locations (1)

Nebraska

  • Celerion Inc. - Lincoln

Trial Details

FieldValue
Enrollment Target 44 participants
Start Date 2021-02-11
Est. Completion 2022-08-16
Phase Phase 1

Sponsor

MassBiologics

6 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04863287

The ClinicalTrials.gov registry entry for NCT04863287 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,869-participant average among 9 other Lyme Disease trials with a reported enrollment target (99% lower). The listed sponsor is MassBiologics, which has 6 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Lyme Disease appearing as the primary indexed condition, and to 2 interventions - of which 2217LS is the first listed.

NCT04863287 reports 1 study location spanning 1 distinct geographic area - top geographies include Nebraska.

Frequently Asked Questions

What is clinical trial NCT04863287 about?

NCT04863287 is a clinical study titled "First Clinical Study of the Safety and Blood Levels of a Human Monoclonal Antibody (2217LS) Against Lyme Disease Bacteria in Healthy People". This is a research study of the investigational drug 2217LS in healthy volunteers. Investigational means 2217LS is a new drug that has not been approved for the treatment of any disease. 2217LS is human antibody designed to provide protection from Lyme disease. Lyme disease is a disease carried by i...

What is the current status of trial NCT04863287?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2021-02-11. Estimated completion is 2022-08-16.

What conditions does trial NCT04863287 study?

This clinical trial studies the following conditions: Lyme Disease.

What interventions are being tested in trial NCT04863287?

The interventions under investigation include: 2217LS (BIOLOGICAL), 0.9% Sodium Chloride (NaCl) (OTHER).

Who is sponsoring clinical trial NCT04863287?

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

Where is trial NCT04863287 being conducted?

This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.