Safety and Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ALXN1910 in Healthy Participants

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study of Subcutaneously and Intravenously Administered ALXN1910 in Healthy Adult Participants

This is a Phase 1, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of single ascending doses (SADs) of ALXN1910 subcutaneous (SC) and SAD of ALXN1910 intravenous (IV).

Inclusion Criteria:

• Healthy participants
• Participants of Japanese descent are defined as: First generation (born to 2 Japanese parents and 4 Japanese grandparents).
• Participants of Japanese descent must be between 20 and 55 years of age.

Exclusion Criteria:

• Current or recurrent disease
• Current or relevant history of physical or psychiatric illness.
• Any other significant disease or disorder that, in the opinion of the Investigator, may put the participant at risk.
• History of significant allergic reaction (eg, anaphylaxis or angioedema) to any product (eg, food, pharmaceutical).
• Female participants who are pregnant or breastfeeding.
• Major surgery or hospitalization within 90 days prior to dosing on Day1.
• History of exposure to asfotase alfa.
• History of allergy or hypersensitivity to excipients of asfotase alfa or ALXN1910 (eg,sodium phosphate, sodium chloride).