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

Alexion Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: ALXN1910

Study type: Interventional

Funder types: Industry

Identifiers

NCT05307978

ALXN1910-HV-101

Details and patient eligibility

About

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).

Enrollment: 48 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 6 patient groups

Cohort 1

Experimental group

Description:

Participants will receive a single dose of 5 mg of ALXN1910 IV or Placebo IV.

Treatment:

Drug: ALXN1910

Drug: Placebo

Cohort 2

Experimental group

Description:

Participants will receive a single dose of 15 mg of ALXN1910 SC or Placebo SC.

Treatment:

Drug: ALXN1910

Drug: Placebo

Cohort 3

Experimental group

Description:

Participant will receive a single dose of 15 mg of ALXN1910 IV or Placebo IV.

Treatment:

Drug: ALXN1910

Drug: Placebo

Cohort 4

Experimental group

Description:

Japanese participants will receive a single dose of 15 mg of ALXN1910 SC or Placebo SC.

Treatment:

Drug: ALXN1910

Drug: Placebo

Cohort 5

Experimental group

Description:

Participants will receive a single dose of 45 mg of ALXN1910 SC or Placebo SC.

Treatment:

Drug: ALXN1910

Drug: Placebo

Cohort 6

Experimental group

Description:

Participants will receive a single dose of 135 mg of ALXN1910 SC or Placebo SC.

Treatment:

Drug: ALXN1910

Drug: Placebo