Safety and Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ALXN1910 in Healthy Participants
NCT ID: NCT05307978
Last Updated: 2025-02-27
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2022-04-12
2023-02-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ALXN1920 in Healthy Participants
NCT05751642
Safety, PK/PD, and Immunogenicity Study of SC ALXN2030 in Healthy Participants
NCT05501717
Study of ALXN1820 in Healthy Adult Participants
NCT04631562
A Study of a Single Subcutaneous Dose of ALXN1210 in Healthy Adult Participants
NCT05288829
A Study of Multiple Doses of ALXN1210 in Healthy Adult Participants
NCT05288673
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort 1
Participants will receive a single dose of 5 mg of ALXN1910 IV or Placebo IV.
ALXN1910
Participants will receive a single dose of ALXN1910 IV or ALXN1910 SC according to their assigned cohort.
Placebo
Participants will receive Placebo IV or Placebo SC according to their assigned cohort.
Cohort 2
Participants will receive a single dose of 15 mg of ALXN1910 SC or Placebo SC.
ALXN1910
Participants will receive a single dose of ALXN1910 IV or ALXN1910 SC according to their assigned cohort.
Placebo
Participants will receive Placebo IV or Placebo SC according to their assigned cohort.
Cohort 3
Participant will receive a single dose of 15 mg of ALXN1910 IV or Placebo IV.
ALXN1910
Participants will receive a single dose of ALXN1910 IV or ALXN1910 SC according to their assigned cohort.
Placebo
Participants will receive Placebo IV or Placebo SC according to their assigned cohort.
Cohort 4
Japanese participants will receive a single dose of 15 mg of ALXN1910 SC or Placebo SC.
ALXN1910
Participants will receive a single dose of ALXN1910 IV or ALXN1910 SC according to their assigned cohort.
Placebo
Participants will receive Placebo IV or Placebo SC according to their assigned cohort.
Cohort 5
Participants will receive a single dose of 45 mg of ALXN1910 SC or Placebo SC.
ALXN1910
Participants will receive a single dose of ALXN1910 IV or ALXN1910 SC according to their assigned cohort.
Placebo
Participants will receive Placebo IV or Placebo SC according to their assigned cohort.
Cohort 6
Participants will receive a single dose of 135 mg of ALXN1910 SC or Placebo SC.
ALXN1910
Participants will receive a single dose of ALXN1910 IV or ALXN1910 SC according to their assigned cohort.
Placebo
Participants will receive Placebo IV or Placebo SC according to their assigned cohort.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ALXN1910
Participants will receive a single dose of ALXN1910 IV or ALXN1910 SC according to their assigned cohort.
Placebo
Participants will receive Placebo IV or Placebo SC according to their assigned cohort.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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).
18 Years
55 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Alexion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clinical Trial Site
Harrow, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ALXN1910-HV-101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.