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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05307978
• Other study ID #: ALXN1910-HV-101
• Status: Completed
• Phase: Phase 1
• Start date: April 12, 2022
• Est. completion date: February 7, 2023

Study information

• Verified date: March 2023
• Source: Alexion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 7, 2023
• Est. primary completion date: February 7, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United Kingdom	Clinical Trial Site	Harrow

Sponsors (1)

Lead Sponsor	Collaborator
Alexion

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)		Day 1 (postdose) through Day 75
Secondary	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
Secondary	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
Secondary	Area Under the Serum Concentration-Time Curve From Time 0 (Dosing) to the Last Quantifiable Concentration (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
Secondary	Number of Participants With Treatment-Emergent Antidrug Antibodies (ADAs)		Day 1 (postdose) through Day 75
Secondary	Plasma Concentration of Inorganic Pyrophosphate (PPi), Pyridoxal-5'-phosphate (PLP), Pyridoxal (PL), and Pyridoxic Acid		Day 1 (predose), 2, 3, 5, 8, 15, 22, 29, 36, 43, and 75
Secondary	Geometric Mean Ratio (GMR) of Area Under the Curve (AUC) Values of Subcutaneous (SC) Versus Intravenous (IV) Serum Concentration of ALXN1910		Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75