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

First Clinical Study of the Safety and Blood Levels of a Human Monoclonal Antibody (2217LS) Against Lyme Disease Bacteria in Healthy People, 2021, MassBiologics, Phase I

Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention 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 (Participant, Care Provider, Investigator)
Primary Purpose: Other
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)
Actual Study Start Date : February 11, 2021
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

https://clinicaltrials.gov/ct2/show/NCT04863287