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

COMPLETEDPHASE1

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 in Healthy Subjects to Evaluate the Safety and Pharmacokinetics of a Human Monoclonal Antibody (2217LS) Against Borrelia Burgdorferi (B. Burgdorferi) Outer Surface Protein A (OspA)

NCT04863287•MassBiologics

View on ClinicalTrials.gov

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.

Eligibility

Age

19 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. 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.
•2. Willing and able to complete all study requirements, restrictions, visits and procedures.
•3. Negative for serum anti-B. burgdorferi antibodies by an FDA approved modified two-tier ELISA test.
•4. Age 19 to 65 years, inclusive.
•5. Weight 50 kg to 105 kg, inclusive.
•6. Seated blood pressure is greater than 90/40 mmHg or less than 140/90 mmHg at the screening visit, and seated heart rate is higher than 40 bpm or lower than 99 bpm at the screening visit.
•7. Women of reproductive potential must agree not to become pregnant for at least 12 months after the study product administration. If a woman is sexually active and has no history of hysterectomy or tubal ligation, she must agree to use hormonal or barrier birth control with spermicidal gel.
•8. Males of reproductive potential must use a barrier method of contraception during the course of the study.
•9. Screening laboratory values must meet the following criteria:
•* WBC \> 3,900 and \< 11,000/mm3
+9 more criteria

Exclusion Criteria

•1. Previous receipt of humanized or human monoclonal antibody whether licensed or investigational.
•2. Positive serology for HIV antibody, HCV antibody or Hepatitis B surface antigen.
•3. Regular use of more than 20 cigarettes per day (or equivalent amount of nicotine containing product)
•4. Drug or alcohol abuse within previous 12 months or a positive screen within 24 hours of study product administration.
•5. History of a previous severe allergic reaction with generalized urticaria, angioedema or anaphylaxis.
•6. Any current medical or other condition that in the opinion of the PI would jeopardize the safety of the volunteer participating in the study.
•7. Clinically significant gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory, or infectious disease, as determined by the PI. The investigator will consider all conditions, which could conceivably increase risk to the subjects, alter study drug metabolism, or jeopardize data integrity as clinically significant when making this determination.
•8. Physical finding on examination considered clinically significant such as murmur (other than functional), hepatosplenomegaly, lymphadenopathy or focal neurological deficit.
•9. Positive serum pregnancy test during screening or within 24 hours of study product administration, or an unwillingness to undergo pregnancy testing.
•10. Breast-feeding.
+5 more criteria

Locations (1)

Celerion Inc.

Lincoln, Nebraska, United States

Key Dates

Start Date

February 11, 2021

Primary Completion Date

August 16, 2022

Completion Date

August 16, 2022

Last Updated

September 16, 2022

Enrollment

ACTUAL participants

Conditions

Lyme Disease

Interventions

2217LS

BIOLOGICAL

0.9% Sodium Chloride (NaCl)

OTHER

A Comprehensive Clinical, Microbiological and Immunological Assessment of Patients With Suspected Post Treatment Lyme Disease Syndrome and Selected Control Populations

NCT00001539

Lyme Disease

View study

RECRUITING

Rheumatology Patient Registry and Biorepository

NCT04402086

Rheumatic DiseasesAdult Onset Still Disease+18 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 16, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Comprehensive Clinical, Microbiological and Immunological Assessment of Patients With Suspected Post Treatment Lyme Disease Syndrome and Selected Control Populations

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