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
1 other identifier
interventional
48
1 country
1
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 ascending doses (SADs) of ALXN1910 subcutaneous (SC) and SAD of ALXN1910 intravenous (IV).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Apr 2022
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2022
CompletedFirst Posted
Study publicly available on registry
April 1, 2022
CompletedStudy Start
First participant enrolled
April 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 7, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 7, 2023
CompletedResults Posted
Study results publicly available
February 27, 2025
CompletedFebruary 27, 2025
January 1, 2025
10 months
March 24, 2022
January 31, 2024
February 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
The safety and tolerability of ALXN1910 was assessed.
Day 1 (postdose) through Day 75
Secondary Outcomes (23)
Maximum Observed Serum Concentration (Cmax)
Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75
Time to Maximum Observed Serum Concentration (Tmax)
Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75
Apparent Terminal Elimination Half Life (t1/2)
Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75
Terminal-phase Elimination Rate Constant (λz)
Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75
AUC From Time Zero to the Last Quantifiable Concentratio (AUCt)
Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75
- +18 more secondary outcomes
Study Arms (6)
Cohort 1
EXPERIMENTALParticipants will receive a single dose of 5 mg of ALXN1910 IV or Placebo IV.
Cohort 2
EXPERIMENTALParticipants will receive a single dose of 15 mg of ALXN1910 SC or Placebo SC.
Cohort 3
EXPERIMENTALParticipant will receive a single dose of 15 mg of ALXN1910 IV or Placebo IV.
Cohort 4
EXPERIMENTALJapanese participants will receive a single dose of 15 mg of ALXN1910 SC or Placebo SC.
Cohort 5
EXPERIMENTALParticipants will receive a single dose of 45 mg of ALXN1910 SC or Placebo SC.
Cohort 6
EXPERIMENTALParticipants will receive a single dose of 135 mg of ALXN1910 SC or Placebo SC.
Interventions
Participants will receive a single dose of ALXN1910 IV or ALXN1910 SC according to their assigned cohort.
Participants will receive Placebo IV or Placebo SC according to their assigned cohort.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Trial Site
Harrow, HA1 3UJ, United Kingdom
Related Links
Limitations and Caveats
For Outcome measure #12 Plasma Concentration of Inorganic Pyrophosphate (PPi); #13 Plasma Concentration of Pyridoxal (PL); #14 Plasma Concentration of Pyridoxal 5-Phosphate (PLP); 15 Plasma Concentration of Pyridoxic Acid (PA); Cohort 4 Day 75 standard deviation is provided for the posting although standard deviation will not be calculated for less than 3 data points per study's Statistical Analysis Plan.
Results Point of Contact
- Title
- Alexion Pharmaceuticals, Inc.
- Organization
- Alexion Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2022
First Posted
April 1, 2022
Study Start
April 12, 2022
Primary Completion
February 7, 2023
Study Completion
February 7, 2023
Last Updated
February 27, 2025
Results First Posted
February 27, 2025
Record last verified: 2025-01