The purpose of the study is to evaluate the safety, tolerability, PK and PD of a single-dose of ALXN1007 in healthy volunteers.
All subjects will be screened for eligibility after providing signed informed consent. Once a subject is determined to be eligible, the subject will be vaccinated with the quadrivalent meningococcal conjugate vaccine at least two weeks prior to dosing, if applicable. A total of 7 dose cohorts will be enrolled sequentially and randomized to receive ALXN1007 or placebo. Subjects will receive ALXN1007 or placebo at the clinic and be kept at the clinic for a total of 4 days for observation and completion of the required study tests. The subjects will return for 8 additional clinic visits to complete the required study tests over the next 86 days. The total duration of the study is 90 days from the day of dosing with ALXN1007 or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
64
PAREXEL Baltimore EPCU
Baltimore, Maryland, United States
Safety and tolerability of a single dose of ALXN1007.
Safety and tolerability of a single dose of ALXN1007 assessed by physical exam, vital signs, ECG, immunogenicity, lab analysis and adverse events.
Time frame: Up to 90 days
PK parameters of ALXN1007
Estimate PK parameters of ALXN1007 using standard measures for these parameters.
Time frame: Up to 90 days
PD parameters of ALXN1007
Identify PD effects of ALXN1007 by assessing standard complement measures for these parameters.
Time frame: Up to 90 days
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