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

Study Identifier:
ALXN1910-HV-101
ClinicalTrials.gov Identifier:
NCT05307978
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete

Available Documents

ProtocolStatistical Analysis Plan

Study Details

Medical Condition
  • Other
Study Drug
  • Drug: ALXN1910
  • Drug: Placebo
Date
Apr 2022 - Feb 2023
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 55 Years
Requirements Information
Inclusion and Exclusion Criteria
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).
Sex
Female & Male
Age
18 - 55 Years

Study Details

Medical Condition
  • Other
Study Drug
  • Drug: ALXN1910
  • Drug: Placebo
Date
Apr 2022 - Feb 2023
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 55 Years years
Requirements Information
Inclusion and Exclusion Criteria
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).

Protocol Summary

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).

Trial Locations

Location
Status
Location
Clinical Trial Site
Harrow, United Kingdom, HA1 3UJ
Status
N/A