| Eligibility |
Inclusion Criteria:
- Healthy male and female participants = 25 and = 55 years old; smokers (no more than 10
cigarettes daily), former smokers (at the Investigator's discretion), or nonsmokers.
- Body mass index from 18 through 29.9 kilogram (kg)/square meter, inclusive, and weight
between 50 and 100 kg, inclusive.
- QT interval (corrected using the Fridericia formula) = 450 milliseconds (ms) for males
and = 470 ms for females at Screening and prior to dosing on Day 1.
- Participant was willing and able to give written informed consent and comply with the
study visit schedule.
- Documented vaccination with tetravalent meningococcal conjugate vaccine (MCV4) at
least 56 days and not more than 3 years prior to dosing. Documentation must have
included a positive serum bactericidal antibody test to confirm an immune response
before the study drug administration.
- Vaccination with serogroup B vaccine at least 56 days prior to dosing on Day 1, with a
booster administered at least 28 days prior to dosing on Day 1.
- Male participants with a female spouse/partner of childbearing potential or a pregnant
or breastfeeding spouse or partner were required to use barrier contraception (male
condom) during the treatment period and for at least 6 months after the last dose of
ALXN1210.
Exclusion Criteria:
- Participants who had intimate and prolonged contact (defined as living under the same
roof or providing personal care) with individuals who were either immunocompromised,
or had specific underlying medical conditions (persons with anatomic or functional
asplenia [including sickle cell disease]; persons with congenital complement,
properdin, factor D, or primary antibody deficiencies, persons with acquired
complement deficiencies [for example, those receiving eculizumab], and persons with
human immunodeficiency virus [HIV]) or with persons younger than 2 years of age or
older than 65 years of age
- Participants who were one of the following: professionals exposed to environments of
greater risk for meningococcal disease; research, industrial, and clinical laboratory
personnel routinely exposed to Neisseria meningitidis; military personnel during
recruit training (military personnel may be at increased risk when accommodated in
close quarters); daycare center workers; those living on a college or university
campus; or those who planned to travel during the course of the study to or had
travelled to endemic areas for meningococcal meningitis (for example, India,
Sub-Saharan Africa, pilgrimage to Saudi Arabia for Hajj) within the past 6 months
- History of any Neisseria infection
- History of unexplained recurrent infection or infection that required treatment with
systemic antibiotics within the last 90 days prior to dosing
- HIV infection (evidenced by HIV-1 or HIV-2 antibody titer)
- Acute or chronic hepatitis B virus infection (evidenced by the presence of hepatitis B
surface antigen or immunoglobulin M antibodies against hepatitis B core antigen)
- Acute or chronic hepatitis C virus infection (evidenced by antibody titer)
- Active systemic viral or fungal infection within 14 days prior to dosing
- Positive or indeterminate QuantiFERON-TB test indicating possible tuberculosis
infection
- History of latent or active tuberculosis or exposure to endemic areas within 8 weeks
prior to the screening visit
- Female participants who were breastfeeding or were of childbearing potential,
including any female who had experienced menarche and who had not undergone successful
surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral
oophorectomy) or who was pregnant, breastfeeding, or not postmenopausal.
- Positive serum pregnancy test at Screening or Day -1
- Serum creatinine > upper limit of normal (ULN) of the reference range of the testing
laboratory at Screening or Day -1.
- Alanine aminotransferase or aspartate aminotransferase > ULN of the reference range of
the testing laboratory at Screening or > 1.5*ULN of the reference range of the testing
laboratory at Day -1.
- Any of the following hematology results: hemoglobin < 135 grams (g)/L for males and <
120 g/L for females; hematocrit < 0.41 L/L for males and < 0.36 L/L for females; white
blood cells < 3.5*10^3/microliter (µL) or > ULN of the testing laboratory reference
range; absolute neutrophils < 1.5*10^3/µL (< 1.0*10^3/µL for black race participants)
or > ULN of the testing laboratory reference range; and platelets < the lower limit of
normal of the testing laboratory reference range or > 450*10^3/µL at Screening or Day
-1; or complete blood count clinical laboratory results considered as clinically
relevant and unacceptable by the Investigator at Day -1.
- History of complement deficiency or complement activity below normal reference range
as evaluated by complement alternative pathway enzyme-linked immunosorbent assay at
Screening.
- History of malignancy, other than basal cell carcinoma that had been treated and had
no evidence of recurrence.
- Participation in a clinical study within 30 days before initiation of dosing on Day 1
or use of any experimental small-molecule therapy within 30 days prior to dosing on
Day 1.
- Participation in more than 1 clinical study of a monoclonal antibody (mAb) or
participation in a clinical study of a mAb within the 12 months prior to Screening
during which the participant was exposed to the active study drug. Participants who
had participated in only 1 study of an mAb were considered for enrollment if they had
completed that study more than 12 months prior to Screening.
- Major surgery or hospitalization within 90 days prior to dosing.
- Contraindication to receiving MCV4 and/or serogroup B vaccine, including severe
(life-threatening) allergic reaction to a previous dose of MCV4 and/or serogroup B
vaccine, severe (life-threatening) allergy to any vaccine component, or previous
diagnosis of Guillain-Barré syndrome.
- History of allergy to excipients of ALXN1210 (that is, polysorbate 80).
- Documented history of allergy to penicillin or cephalosporin.
- History of significant allergic reaction (anaphylaxis, angioedema) to any product
(food, pharmaceutical, etc).
- Positive urine drug toxicology screen at Screening or Day -1.
- Donation of plasma within 7 days prior to dosing. Donation or loss (excluding volume
drawn at Screening) of more than 50 mL of blood within 30 days of dosing or more than
499 mL of blood within 56 days of dosing.
- Use of prescription medications within 28 days prior to study drug administration.
- Clinical diagnosis of any autoimmune or rheumatologic disease (for example, systemic
lupus erythematosus, rheumatoid arthritis).
- Immunization with a live-attenuated vaccine 1 month prior to dosing or planned
vaccination during the course of the study (except for the vaccination planned by the
study protocol).
- Presence of fever (confirmed body temperature > 37.6°C; for example, a fever
associated with a symptomatic viral or bacterial infection) within 14 days prior to
the first dose.
- Participants with any medical history, conditions or risks that, in the opinion of the
Investigator, would have interfered with the participant's full participation in the
study or compliance with the protocol, posed any additional risk for the participant,
or confounded the assessment of the participant or outcome of the study.
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