Lyme DiseasePhase 1NCT04863287

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 testing 2217LS and 0.9% Sodium Chloride (NaCl) in people with Lyme Disease, run by MassBiologics at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 19 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Lyme Disease
What is being tested?: 2217LS and 0.9% Sodium Chloride (NaCl)
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 44 participants
Where: 1 siteUnited States
Study dates: 11 Feb 2021to 16 Aug 2022
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.
Negative for serum anti-B. burgdorferi antibodies by an FDA approved modified two-tier ELISA test.
Age 19 to 65 years, inclusive.
Weight 50 kg to 105 kg, inclusive.
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.

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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.
Males of reproductive potential must use a barrier method of contraception during the course of the study.
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

Who cannot join

Previous receipt of humanized or human monoclonal antibody whether licensed or investigational.
Positive serology for HIV antibody, HCV antibody or Hepatitis B surface antigen.
Regular use of more than 20 cigarettes per day (or equivalent amount of nicotine containing product)
Drug or alcohol abuse within previous 12 months or a positive screen within 24 hours of study product administration.
History of a previous severe allergic reaction with generalized urticaria, angioedema or anaphylaxis.
Any current medical or other condition that in the opinion of the PI would jeopardize the safety of the volunteer participating in the study.

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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.
Physical finding on examination considered clinically significant such as murmur (other than functional), hepatosplenomegaly, lymphadenopathy or focal neurological deficit.
Positive serum pregnancy test during screening or within 24 hours of study product administration, or an unwillingness to undergo pregnancy testing.
Breast-feeding.
Treatment with another investigational drug or other investigational intervention within 30 days of study drug dosing.
Safety laboratory abnormalities at Screening or Day -1, which are clinically significant as determined by the PI.
Tick bite within 4 weeks prior to screening.
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.
Potential study subjects who met all inclusion and none of the exclusion criteria, but who, for personal or administrative reasons, were not included in a study cohort, may be rescreened if more than 30 days have passed since their previous screening. There are no restrictions on the number of re-screens permitted for these subjects.

Trial locations and contacts

1 site in 1 country.

United States1 site

Celerion Inc.
Lincoln, Nebraska, 68502

Other trials in United States

About this study

Official title: 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)

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: Lyme Disease
Being tested: 2217LS, 0.9% Sodium Chloride (NaCl)
Keywords: LYME, Lyme bacteria, Borrelia burgdorferi (B. burgdorferi), Human Monoclonal Antibody, Outer surface protein A (OspA)
Medical subject headings: Lyme Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

2217LSBiological
Fully Human Monoclonal Antibody
0.9% Sodium Chloride (NaCl)Other
Subcutaneous injection

Study groups in NCT04863287
Study group	Role	What they receive
0.5 mg/kg of 2217LS	Experimental	Single dose subcutaneous injection Receives: Biological: 2217LS
1.5 mg/kg of 2217LS	Experimental	Single dose subcutaneous injection Receives: Biological: 2217LS
5 mg/kg of 2217LS	Experimental	Single dose subcutaneous injection Receives: Biological: 2217LS
10 mg/kg of 2217LS	Experimental	Single dose subcutaneous injection Receives: Biological: 2217LS
0.9% Sodium Chloride (NaCl)	Placebo comparator	Single dose subcutaneous injection Receives: Other: 0.9% Sodium Chloride (NaCl)

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and tolerability of a study treatment by number of adverse events reported
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 for industry. Adverse events will be summarized by System Organ Class (SOC) using MedDRA.
Measured: Day 1 through Day 360

Secondary outcomes (4)

Pharmacokinetics (PK) parameter: Maximum serum concentration observed (Cmax) of 2217LS
Serial measurements of 2217LS concentration in the serum.
Measured: 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
Pharmacokinetics (PK) parameter: Area under the curve (AUC) of 2217LS
Serial measurements of 2217LS concentration in the serum.
Measured: 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
Pharmacokinetics (PK) parameter: Serum half life (T 1/2) of 2217LS
Serial measurements of 2217LS concentration in the serum.
Measured: 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
Assessment of immunogenicity anti-drug antibodies (ADA) of 2217LS
Serial measurements of 2217LS concentration in the serum.
Measured: 10 Study Days - Day 1 Pre-Dose, Day 8 or 9, 14 or 15, 29, 60, 90, 120, 180, 240, 360

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Feb 202116 Aug 2022

First posted28 Apr 2021
Study start11 Feb 2021
Primary completion16 Aug 2022
Study completion16 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Lyme DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Sequential
Model description: 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.
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04863287
Sponsor's protocol ID: MBL-LYME-20-01
Status last verified: Sep 2022
First submitted: 14 Apr 2021
Last updated: 16 Sep 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT04863287
Acronym / sponsor ID: MBL-LYME-20-01
Conditions: Lyme Disease
Keywords: LYME, Lyme bacteria, Borrelia burgdorferi (B. burgdorferi), Human Monoclonal Antibody, Outer surface protein A (OspA)
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: MassBiologicsUniversity, hospital or other
Collaborators: Celerion
Study start: 11 Feb 2021 (actual)
Primary completion: 16 Aug 2022 (actual)
Study completion: 16 Aug 2022 (actual)
First posted: 28 Apr 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 5
Model description: 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.

Arm	Type	Receives
0.5 mg/kg of 2217LS	Experimental	Biological: 2217LSSingle dose subcutaneous injection
1.5 mg/kg of 2217LS	Experimental	Biological: 2217LSSingle dose subcutaneous injection
5 mg/kg of 2217LS	Experimental	Biological: 2217LSSingle dose subcutaneous injection
10 mg/kg of 2217LS	Experimental	Biological: 2217LSSingle dose subcutaneous injection
0.9% Sodium Chloride (NaCl)	Placebo comparator	Other: 0.9% Sodium Chloride (NaCl)Single dose subcutaneous injection

Who may qualify

Ages: 19 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (19 listed)

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.
Negative for serum anti-B. burgdorferi antibodies by an FDA approved modified two-tier ELISA test.
Age 19 to 65 years, inclusive.
Weight 50 kg to 105 kg, inclusive.

Key exclusion criteria (16 listed)

Previous receipt of humanized or human monoclonal antibody whether licensed or investigational.
Positive serology for HIV antibody, HCV antibody or Hepatitis B surface antigen.
Regular use of more than 20 cigarettes per day (or equivalent amount of nicotine containing product)
Drug or alcohol abuse within previous 12 months or a positive screen within 24 hours of study product administration.
History of a previous severe allergic reaction with generalized urticaria, angioedema or anaphylaxis.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
2217LSFully Human Monoclonal Antibody	Biological	0.5 mg/kg of 2217LS, 1.5 mg/kg of 2217LS, 10 mg/kg of 2217LS, 5 mg/kg of 2217LS
0.9% Sodium Chloride (NaCl)Subcutaneous injection	Other	0.9% Sodium Chloride (NaCl)

Primary outcome

Safety and tolerability of a study treatment by number of adverse events reported
Time frame: Day 1 through Day 360
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 for industry. Adverse events will be summarized by System Organ Class (SOC) using MedDRA.

4 secondary outcomes

Pharmacokinetics (PK) parameter: Maximum serum concentration observed (Cmax) of 2217LS
Time frame: 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
Pharmacokinetics (PK) parameter: Area under the curve (AUC) of 2217LS
Time frame: 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
Pharmacokinetics (PK) parameter: Serum half life (T 1/2) of 2217LS
Time frame: 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
Assessment of immunogenicity anti-drug antibodies (ADA) of 2217LS
Time frame: 10 Study Days - Day 1 Pre-Dose, Day 8 or 9, 14 or 15, 29, 60, 90, 120, 180, 240, 360

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 2217LS and 0.9% Sodium Chloride (NaCl) in people with Lyme Disease, run by MassBiologics at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability of a study treatment by number of adverse events reported (time frame: Day 1 through Day 360). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04863287.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2022.