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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
44
Fully Human Monoclonal Antibody
Subcutaneous injection
Celerion Inc.
Lincoln, Nebraska, United States
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.
Time frame: Day 1 through Day 360
Pharmacokinetics (PK) parameter: Maximum serum concentration observed (Cmax) of 2217LS
Serial measurements of 2217LS concentration in the serum.
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
Serial measurements of 2217LS concentration in the serum.
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
Serial measurements of 2217LS concentration in the serum.
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
Serial measurements of 2217LS concentration in the serum.
Time frame: 10 Study Days - Day 1 Pre-Dose, Day 8 or 9, 14 or 15, 29, 60, 90, 120, 180, 240, 360
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