Phase 1 Single Dose Study of ALXN1101 in Healthy Volunteers

This is a first-in-human (FIH), randomized, blinded, placebo-controlled, single-dose, sequential-cohort, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics (PK) of a single dose of ALXN1101 in healthy adult subjects.

Key Inclusion Criteria:

• Male or female subjects ≥ 18 and ≤ 60 years of age and weight ≥ 55 kg and ≤ 100 kg
• Willing and able to give written informed consent
• Female subjects of child bearing potential must have a negative serum pregnancy test or must be practicing an approved contraceptive regimen for the duration of the study
• Male subjects must be practicing an acceptable barrier method of contraception

Key Exclusion Criteria:

• Pregnant or nursing female subjects
• QTcF > 450 msec for males and > 470 msec for females, or a family history of Long QT Syndrome.
• CrCl < 80 mL/min
• CBC in acceptable range; SGOT or SGPT above the ULN
• HIV, Hepatitis B or Hepatitis C virus infection
• Other active systemic infection or malignancy
• Investigational drug study within 60 days
• Major surgery within the prior 90 days
• History of illicit drug use or chronic alcohol dependence within 2 years prior to this study
• Positive urine drug toxicology screen or serum alcohol test
• Alcohol consumption within 48 hours prior to study drug administration
• Recently donated or lost ≥ 499 mL of blood
• Recent hormone replacement therapy or use of prescription medications