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2217LS for Lyme Disease

Phase 1
Waitlist Available
Research Sponsored by MassBiologics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Capable of giving written informed consent and able to effectively communicate with the Investigator and study personnel. A signed informed consent form (ICF) must be on file prior to initiating the screening procedures.
Willing and able to complete all study requirements, restrictions, visits and procedures.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 study days - day-1 pre dose, day 2 or 3, 4 or 5, 6 or 7, 8 or 9, 10 or 11, 14 or 15, 29, 60, 90, 120, 180, 240, 360
Awards & highlights

Study Summary

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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 study days - day-1 pre dose, day 2 or 3, 4 or 5, 6 or 7, 8 or 9, 10 or 11, 14 or 15, 29, 60, 90, 120, 180, 240, 360
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 study days - day-1 pre dose, day 2 or 3, 4 or 5, 6 or 7, 8 or 9, 10 or 11, 14 or 15, 29, 60, 90, 120, 180, 240, 360 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and tolerability of a study treatment by number of adverse events reported
Secondary outcome measures
Assessment of immunogenicity anti-drug antibodies (ADA) of 2217LS
Pharmacokinetics (PK) parameter: Area under the curve (AUC) of 2217LS
Pharmacokinetics (PK) parameter: Maximum serum concentration observed (Cmax) of 2217LS
+1 more

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: 5 mg/kg of 2217LSExperimental Treatment1 Intervention
Single dose subcutaneous injection
Group II: 10 mg/kg of 2217LSExperimental Treatment1 Intervention
Single dose subcutaneous injection
Group III: 1.5 mg/kg of 2217LSExperimental Treatment1 Intervention
Single dose subcutaneous injection
Group IV: 0.5 mg/kg of 2217LSExperimental Treatment1 Intervention
Single dose subcutaneous injection
Group V: 0.9% Sodium Chloride (NaCl)Placebo Group1 Intervention
Single dose subcutaneous injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
2217LS
2021
Completed Phase 1
~50

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

MassBiologicsLead Sponsor
5 Previous Clinical Trials
296 Total Patients Enrolled
CelerionIndustry Sponsor
80 Previous Clinical Trials
7,713 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~11 spots leftby Mar 2025