Skip to main content
OpenTrials
Completed

NCT Number: NCT05307978

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Trial Site

Harrow, HA1 3UJ, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

ALXN1910

Drug

Participants will receive a single dose of ALXN1910 IV or ALXN1910 SC according to their assigned cohort.

Placebo

Drug

Participants will receive Placebo IV or Placebo SC according to their assigned cohort.

Primary outcomes

  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

    Time frame: Day 1 (postdose) through Day 75

    The safety and tolerability of ALXN1910 was assessed.

Secondary outcomes

  1. Maximum Observed Serum Concentration (Cmax)

    Time frame: Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75

    The Cmax was assessed as PK parameter of single ascending doses of ALXN1910.

  2. Time to Maximum Observed Serum Concentration (Tmax)

    Time frame: Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75

    The Tmax was assed as PK parameter of single ascending doses of ALXN1910.

  3. Apparent Terminal Elimination Half Life (t1/2)

    Time frame: Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75

    The t1/2 was assed as PK parameter of single ascending doses of ALXN1910.

  4. Terminal-phase Elimination Rate Constant (λz)

    Time frame: Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75

    The λz was assed as PK parameter of single ascending doses of ALXN1910.

  5. AUC From Time Zero to the Last Quantifiable Concentratio (AUCt)

    Time frame: Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75

    The AUCt was assed as PK parameter of single ascending doses of ALXN1910.

  6. AUC From Time Zero Extrapolated to Infinity (AUC∞)

    Time frame: Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75

    The AUC∞ was assed as PK parameter of single ascending doses of ALXN1910.

  7. AUC From Time Zero to 168h (AUC0-168)

    Time frame: Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75

    The AUC0-168 was assed as PK parameter of single ascending doses of ALXN1910.

  8. Percentage of AUC∞ Obtained by Extrapolation Beyond Tlast (%AUCex)

    Time frame: Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75

    The %AUCex was assed as PK parameter of single ascending doses of ALXN1910.

  9. Total Body Clearance (for IV Cohorts) or Apparent Clearance (for SC Cohorts) (CL or CL/F)

    Time frame: Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75

    The CL or CL/F was assed as PK parameter of single ascending doses of ALXN1910.

  10. Volume of Distribution (for IV Cohorts) or Apparent Volume of Distribution (for SC Cohorts) (Vd or Vd/F)

    Time frame: Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75

    The Vd or Vd/F was assed as PK parameter of single ascending doses of ALXN1910.

  11. Plasma Concentration of Inorganic Pyrophosphate (PPi)

    Time frame: Day 1 (predose), 2, 3, 5, 8, 15, 22, 29, 36, 43, and 75

    The plasma concentrations of PPi was assesed.

  12. Plasma Concentration of Pyridoxal (PL)

    Time frame: Day 1 (predose), 2, 3, 5, 8, 15, 22, 29, 36, 43, and 75

    The plasma concentrations of PL was assessed.

  13. Plasma Concentration of Pyridoxal 5-Phosphate (PLP)

    Time frame: Day 1 (predose), 2, 3, 5, 8, 15, 22, 29, 36, 43, and 75

    The plasma concentrations of PLP was assessed.

  14. Plasma Concentration of Pyridoxic Acid (PA)

    Time frame: Day 1 (predose), 2, 3, 5, 8, 15, 22, 29, 36, 43, and 75

    The plasma concentrations of PA was assessed.

  15. Number of Participants With Positive Treatment-Emergent Antidrug Antibodies (ADAs)

    Time frame: Day 1 (postdose) through Day 75

    The ADAs of ALXN1910 was assessed as immunogenicity parameter. Treatment-emergent ADA Responses is defined as a positive result in the ADA assay post first dose, when baseline results are negative or missing.

  16. Geometric Mean Ratio (GMR) of Area Under the Curve (AUC∞) Values of Subcutaneous (SC) Versus Intravenous (IV) Serum Concentration of ALXN1910

    Time frame: Up to Day 75

    The absolute bioavailability GMR AUC∞ of ALXN1910 SC was assessed.

  17. Maximum Observed Serum Concentration (Cmax) in Japanese and Non-Japanese Participants

    Time frame: Up to Day 75

    Quantitative assessment of PK parameter (Cmax) was assessed between Japanese and non-Japanese participants.

  18. AUC From Time Zero to the Last Quantifiable Concentration (AUCt) in Japanese and Non-Japanese Participants

    Time frame: Up to Day 75

    Quantitative assessment of PK parameter (AUCt) was assessed between Japanese and non-Japanese participants.

  19. AUC From Time Zero Extrapolated to Infinity (AUC∞) in Japanese and Non-Japanese Participants

    Time frame: Up to Day 75

    Quantitative assessment of PK parameter (AUC∞) was assessed between Japanese and non-Japanese participants.

  20. Change From Baseline in Inorganic Pyrophosphate Concentration in Japanese and Non-Japanese Participants

    Time frame: Day 2, 15, 22, 43, and 75

    Change from baseline in PD parameter Inorganic Pyrophosphate was evaluated over time for Japanese and non-Japanese participants (Cohort 2 versus Cohort 4) on active treatment.

  21. Change From Baseline in Pyridoxal-5-phosphate Concentration in Japanese and Non-Japanese Participants

    Time frame: Day 2, 15, 22, 43, and 75

    Change from baseline in PD parameter Pyridoxal-5-phosphate was evaluated over time for Japanese and non-Japanese participants (Cohort 2 versus Cohort 4) on active treatment

  22. Change From Baseline in Pyridoxal Concentration in Japanese and Non-Japanese Participants

    Time frame: Day 2, 15, 22, 43, and 75

    Change from baseline in PD parameter Pyridoxal was evaluated over time for Japanese and non-Japanese participants (Cohort 2 versus Cohort 4) on active treatment.

  23. Change From Baseline in Pyridoxic Acid Concentration in Japanese and Non-Japanese Participants

    Time frame: Day 2, 15, 22, 43, and 75

    Change from baseline in PD parameter Pyridoxic Acid was evaluated over time for Japanese and non-Japanese participants (Cohort 2 versus Cohort 4) on active treatment.

Sponsors and collaborators

Lead sponsor

Alexion Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study of Subcutaneously and Intravenously Administered ALXN1910 in Healthy Adult Participants

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 1, 2022
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.