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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-11

Study Completion Date

2022-08-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Phase 1/2 Lyme Vaccine Study

NCT01504347

Prophylaxis of Lyme Borreliosis

COMPLETED PHASE1/PHASE2

A Study to Evaluate the Safety and Immunogenicity of mRNA-1975 and mRNA-1982 Against Lyme Disease in Participants 18 Through 70 Years of Age

NCT05975099

Lyme Disease

COMPLETED PHASE1/PHASE2

A Study to Learn About Different Dosing Schedules of a Lyme Disease Vaccine in Healthy Adults

NCT07226882

Lyme Borreliosis

RECRUITING PHASE3

Next Generation Sequencing Detection of Lyme Disease

NCT03505879

Lyme Disease Pediatric Infectious Disease Erythema Migrans +3 more

COMPLETED

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of the Safety and Efficacy of Ceftriaxone and Doxycycline in the Treatment of Patients With Seronegative Chronic Lyme Disease

NCT00000938

Lyme Disease

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lyme Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Randomized, partial-blind, placebo controlled, sequential, dose escalation study, consisting of four cohorts of 10 subjects. Each cohort will have a sentinel group consisting of 2 subjects randomized 1:1 to receive 2217LS or placebo. Sentinel subjects will be dosed first. If judged safe and well tolerated by the Principal Investigator (PI) and if the stopping rules have not been met, the remaining 8 subjects in the cohort will be randomized 7:1 to 2217LS or placebo, respectively and dosed no less than 24 hours after dosing of sentinel subjects has been completed.

For each cohort, safety and pharmacokinetic (PK) data will be reviewed by the PI, Independent Medical Monitor (IMM) and Sponsor prior to dosing the next cohort. A minimum of 7 days of safety data and available PK data from a minimum of 8 subjects from the preceding cohort must be reviewed. Dosing of the next cohort may proceed upon agreement between the PI, IMM and Sponsor, if the stopping rules have not been met.

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Intervention Type OTHER

Subcutaneous injection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

2217LS

Fully Human Monoclonal Antibody

Intervention Type BIOLOGICAL

0.9% Sodium Chloride (NaCl)

Subcutaneous injection

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
* Platelets \> 100,000/mm3
* Hemoglobin \> 10.5 gm/dl
* Creatinine ≤ ULN
* BUN ≤ ULN
* AST ≤ ULN
* ALT ≤ ULN
* Alkaline Phosphatase ≤ ULN
* Total Bilirubin \< 1.5 x ULN AND Direct Bilirubin ≤ ULN
* HgbA1c ≤ 6.4

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.
11. Treatment with another investigational drug or other investigational intervention within 30 days of study drug dosing.
12. Safety laboratory abnormalities at Screening or Day -1, which are clinically significant as determined by the PI.
13. Tick bite within 4 weeks prior to screening.
14. Receipt of any Lyme disease vaccine.

Abnormal ECG or laboratory parameters may be repeated once, if in the opinion of the PI, the results are due to technical factors or are inconsistent with the potential subject's medical evaluation.

Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes