| Eligibility |
Inclusion Criteria:
- 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 Fridericia's formula = 450 milliseconds (msec) for males
and = 470 msec for females at Screening and prior to dosing on Day 1.
- Was willing and was able to give written informed consent and complied with the study
visit schedule.
- Documented vaccination with tetravalent meningococcal conjugate vaccine at least 56
days and not more than 3 years prior to dosing. Documentation must have included a
positive serum bactericidal antibody titer to confirm an immune response before study
drug administration.
- Vaccination with serogroup B meningococcal 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, with at
least 28 days between the first and second injections.
- Female participants of childbearing potential, if heterosexually active, must use
highly effective contraception.
Exclusion Criteria:
- Participants who were in intimate and prolonged contact with (defined as living under
the same roof or providing personal care to) people younger than 2 years of age or
older than 65 years of age, or who were either immunocompromised or had 1 of the
following underlying medical conditions: anatomic or functional asplenia (including
sickle cell disease); congenital complement, properdin, factor D, or primary antibody
deficiencies; acquired complement deficiencies (for example, those receiving
eculizumab); or human immunodeficiency virus (HIV).
- 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 could have been at increased risk of
meningococcal infection when accommodated in close quarters); daycare center workers;
those living on a college or university campus; and 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, or pilgrimage to Saudi Arabia for
Hajj) within the past 6 months.
- History of any Neisseria infection.
- History of unexplained, recurrent infection, or infection requiring treatment with
systemic antibiotics within 90 days prior to dosing.
- Evidence of HIV infection (HIV-1 or HIV-2 antibody titer).
- Acute or chronic hepatitis B virus infection. Hepatitis B surface antigen (HBsAg)
testing was required for all participants prior to enrollment. Participants with
positive HBsAg were not enrolled. For participants with negative HBsAg, the following
testing algorithm was required: If hepatitis B core antibody (HBcAb) was negative, the
participant was eligible to enroll and If HBcAb was positive, the hepatitis B surface
antibody (HBsAb) was tested. (If both HBcAb and HBsAb were positive, the participant
was eligible to enroll and If HBcAb was positive and HBsAb was negative, the
participant was not enrolled.)
- 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 which indicated possible tuberculosis
(TB) infection.
- History of latent or active TB or exposure to endemic areas within 8 weeks prior to
the Screening visit.
- Female participants who are breastfeeding or are heterosexually active and unwilling
to practice contraception and are not postmenopausal.
- Positive serum pregnancy test at Screening or on Day -1.
- Serum creatinine greater than the upper limit of normal (ULN) of the reference range
of the testing laboratory at Screening or on 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 on Day -1.
- Any of the following hematology results: hemoglobin < 130 grams (g)/liter for males
and < 115 g/L for females, hematocrit < 0.37 L/L for males and < 0.33 L/L for females,
white blood cell count < 3.0*10^3/microliter (µL), absolute neutrophil count <
2.0*10^3/µL, and platelet count < 150 or > 400*10^3/µL at Screening or on Day -1.
Complete blood count clinical laboratory results that were considered clinically
relevant and unacceptable by the Investigator at Day -1.
- History of complement deficiency or complement activity below the normal reference
range as evaluated by complement alternative pathway enzyme-linked immunosorbent assay
at Screening.
- History of malignancy with the exception of a nonmelanoma skin cancer or carcinoma in
situ of the cervix that had been treated with 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 participants was exposed to the active study drug. Participants who
participated in only 1 study of a mAb could have been considered for enrollment if
they completed that study more than 12 months prior to screening.
- Prior exposure to ALXN1210.
- Major surgery or hospitalization within 90 days prior to dosing.
- History of allergy to excipients of ALXN1210 (for example, polysorbate 80).
- Documented history of allergy to penicillin or cephalosporin.
- History of significant allergic reaction (for example, anaphylaxis or angioedema) to
any product (food, pharmaceutical, etc).
- Smoked > 10 cigarettes daily (former smokers could have been permitted to enroll at
the Investigator's discretion).
- Positive urine drug toxicology screen at Screening or on 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 prior to dosing or more
than 499 mL of blood within 56 days prior to dosing.
- Clinical diagnosis of any autoimmune or rheumatologic disease (for example, systemic
lupus erythematosus, and rheumatoid arthritis).
- Immunization with a live-attenuated vaccine 28 days prior to dosing or planned
vaccination during the course of the study (except for the vaccination planned per
protocol). Immunization with inactivated or recombinant influenza vaccine was
permitted.
- 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
dosing.
- Participants with any medical history, conditions, or risks that, in the opinion of
the Investigator, could have interfered with the participant's full participation in
the study or compliance with the protocol, or could have posed any additional risk for
the participant or confounded the assessment of the participant or the outcome of the
study.
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