Safety, PK/PD, and Immunogenicity Study of SC ALXN2030 in Healthy Participants

Healthy Clinical Trial

Official title:

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study of Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Subcutaneous ALXN2030 in Healthy Participants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05501717
• Other study ID #: ALXN2030-HV-101
• Status: Recruiting
• Phase: Phase 1
• Start date: August 16, 2022
• Est. completion date: February 4, 2025

Study information

• Verified date: March 2024
• Source: Alexion Pharmaceuticals, Inc.
• Contact: Alexion Pharmaceuticals, Inc. (Sponsor)
• Phone: 1-855-752-2356
• Email: clinicaltrials[@]alexion.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study is to assess the safety and tolerability of single ascending doses of ALXN2030 in healthy participants.

Description:

Approximately 48 healthy adult participants (36 participants will be on ALXN2030 and 12 participants will be on placebo) are expected to be enrolled.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: February 4, 2025
• Est. primary completion date: February 4, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy participants

• QTcF = 450 msec at Screening and on admission (ie, on Day -1).

• 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 60 years of age.

• BMI within the range 18-32kg/m2 (inclusive) at Screening.

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.

• Female participants who are pregnant or breastfeeding.

• Major surgery or hospitalization within 90 days prior to dosing on Day1.

• History of allergy or hypersensitivity to an oligonucleotide or GalNAc moiety or any excipients of ALXN2030.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• ALXN2030
ALXN2030 will be administered subcutaneously as a single dose either as a manual SC injection or as an SC infusion via a syringe pump.
• Placebo
Placebo will be administered subcutaneously as a single dose either as a manual SC injection or as an SC infusion via a syringe pump.

Locations

Country	Name	City	State
United Kingdom	Clinical Trial Site	Harrow
United Kingdom	Research Site	Harrow

Sponsors (1)

Lead Sponsor	Collaborator
Alexion Pharmaceuticals, Inc.

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 through through study completion, an average of 1 year
Secondary	Maximum Observed Plasma Concentration (Cmax)		Days 1 (predose; end of infusion (EOI); and 0.25, 0.5, 1, 2, 4, 6, 8, and 12 hours post-EOI), 2, 3, 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, and 127
Secondary	Time to Maximum Observed Plasma Concentration (Tmax)		Days 1 (predose; EOI; and 0.25, 0.5, 1, 2, 4, 6, 8, and 12 hours post-EOI), 2, 3, 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, and 127
Secondary	Area Under the Plasma Concentration Versus Time Curve From Time 0 (Dosing) to the Last Quantifiable Concentration (AUCt)		Days 1 (predose; EOI; and 0.25, 0.5, 1, 2, 4, 6, 8, and 12 hours post-EOI), 2, 3, 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, and 127
Secondary	Change from Baseline in Plasma Concentration of Complement Component 3 (C3) Protein		Baseline (Day 1) and study completion, an average of 1 year
Secondary	Change from Baseline in Serum Complement Functional Activity		Baseline (Day 1) and Day 127
Secondary	Number of Participants With Treatment-Emergent Antidrug Antibodies (ADAs)		Days 1 through study completion, an average of 1 year