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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: Completed Phase 1 study of Lyme Disease, sponsored by MassBiologics.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Adverse events will be assessed by targeted medical history, physical examination, and laboratory testing. Abnormal laboratory values constitute adverse events only if they induce signs or symptoms and/or require therapy that are new or enhanced from baseline. Injection site reactions (pain, tenderness, erythema/redness, and induration/swelling) will be evaluated pre-dose through Day 15. The reactions are rated Mild (Grade 1), Moderate (Grade 2), and Severe (Grade 3) according to FDA guidance fo
Conditions Studied
Interventions
- BIOLOGICAL 2217LS
- OTHER 0.9% Sodium Chloride (NaCl)
Study Locations (1)
Nebraska
- Celerion Inc. - Lincoln
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2021-02-11 |
| Est. Completion | 2022-08-16 |
| Phase | Phase 1 |
What the finished NCT04863287 record still lists
NCT04863287 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 3,869-participant average among 9 other Lyme Disease trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT04863287's enrollment target sits among peer trials
44 8th of 9 higher than 2 of 9 other Lyme Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lyme Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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