Status:
COMPLETED
Safety and Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ALXN1910 in Healthy Participants
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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 ascendin...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
April 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 7 2023
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT05307978
Start Date
April 12 2022
End Date
February 7 2023
Last Update
February 27 2025
Active Locations (1)
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1
Clinical Trial Site
Harrow, United Kingdom, HA1 3UJ