A Study of ALXN1830 in Healthy Adult Participants

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of Subcutaneous ALXN1830 in Healthy Participants

This trial will study the effects of single and multiple doses of ALXN1830 in healthy adult participants.

Study Overview

• Status: Terminated
• Conditions: Healthy
• Intervention / Treatment: Drug: ALXN1830; Drug: Placebo

Detailed Description

This is a Phase 1 study in healthy adult participants. The study will consist of 2 single ascending dose (Cohorts 1 and 2) and 4 multiple ascending dose cohorts (Cohorts 3 to 6). Participants will be randomly assigned to each of the 6 cohorts to receive either single or multiple doses of ALXN1830 subcutaneous (SC) or single or multiple doses of placebo SC. Cohort 6 will enroll only healthy participants of Japanese descent who will be dosed according to the highest tolerated dose (HTD) established in the non-Japanese cohorts.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 1

Contacts and Locations

Study Locations

• New Zealand
  • Auckland, New Zealand
    • Clinical Trial Site
  • Grafton, New Zealand, 1010
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Satisfactory medical assessment.
• Participants must have had vaccination against pneumococcus (Pneumovax 23 [PPSV23]) at least 28 days, and maximally 4 years prior to Day 1.
• Participants must have had seasonal influenza vaccination for the current season at least 28 days prior to Day 1.
• Body weight within 60 to 90 kilograms (kg), inclusive, and body mass index within 18 to 30 kg/meter squared, inclusive.
• Must be willing to follow protocol-specified contraception guidance during the study and for 3 months after last dose of study drug.

Exclusion Criteria:

• Current/recurrent diseases or relevant medical history.
• Known exposure to investigational or marketed therapeutic proteins, such as monoclonal antibodies, fusion proteins, bispecific molecules, or antibody drug conjugates, within 60 days or 5 half-lives (whichever is longer) prior to dosing.
• Participants who have prior exposure to ALXN1830.
• Current enrollment or past participation within the last 90 days before signing of consent in this or any other interventional clinical study.
• Participants with hepatitis B or C, or human immunodeficiency virus.
• Participants who are either immunocompromised or have one of the following underlying medical conditions: anatomic or functional asplenia (including sickle cell disease); primary antibody deficiencies.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: ALXN1830 Single Dose 1/Placebo; Participants will receive a single SC dose of ALXN1830 or placebo.	Drug: ALXN1830; ALXN1830 will be administered as SC infusion(s).; Drug: Placebo; Placebo will be administered as SC infusion(s).; Other Names: Normal Saline
Experimental: Cohort 2: ALXN1830 Single Dose 2/Placebo; Participants will receive a single SC dose of ALXN1830 or placebo.	Drug: ALXN1830; ALXN1830 will be administered as SC infusion(s).; Drug: Placebo; Placebo will be administered as SC infusion(s).; Other Names: Normal Saline
Experimental: Cohort 3: ALXN1830 Multiple Dose 1/Placebo; Participants will receive multiple SC doses of ALXN1830 or placebo.	Drug: ALXN1830; ALXN1830 will be administered as SC infusion(s).; Drug: Placebo; Placebo will be administered as SC infusion(s).; Other Names: Normal Saline
Experimental: Cohort 4: ALXN1830 Multiple Dose 2/Placebo; Participants will receive multiple SC doses of ALXN1830 or placebo.	Drug: ALXN1830; ALXN1830 will be administered as SC infusion(s).; Drug: Placebo; Placebo will be administered as SC infusion(s).; Other Names: Normal Saline
Experimental: Cohort 5: ALXN1830 Multiple Dose 3/Placebo; Participants will receive multiple SC doses of ALXN1830 or placebo.	Drug: ALXN1830; ALXN1830 will be administered as SC infusion(s).; Drug: Placebo; Placebo will be administered as SC infusion(s).; Other Names: Normal Saline
Experimental: Cohort 6: ALXN1830 /Placebo in Japanese Population; Japanese participants will receive multiple SC doses of ALXN1830 (HTD) or placebo.	Drug: ALXN1830; ALXN1830 will be administered as SC infusion(s).; Drug: Placebo; Placebo will be administered as SC infusion(s).; Other Names: Normal Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	An AE was any untoward medical occurrence in a participant administered the study drug and which did not necessarily have a causal relationship with this treatment. A TEAE was defined as an AE with a start date or time on or after the first dose of the study intervention. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.	Day 1 (postdose) through follow-up (up to approximately 141 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Single-Dose Cohorts: Area Under the Serum Concentration-time Curve From Time 0 (Dosing) To Time Infinity (AUC0-inf) of ALXN1830	Serum total drug concentrations were measured using a validated liquid chromatography/mass spectrometry (LC/MS) assay.	Day 1 (predose) up to Day 64 (postdose)
Multiple-Dose Cohorts: AUC0-inf of ALXN1830 at Day 1	Serum total drug concentrations were measured using a validated LC/MS assay.	Day 1 (predose up to 12 hours postdose)
Multiple-Dose Cohorts: AUC0-inf of ALXN1830 at Day 22	Serum total drug concentrations were measured using a validated LC/MS assay.	Day 22 (predose up to 12 hours postdose)
Multiple-Dose Cohorts: AUC0-inf of ALXN1830 at Day 78	Serum total drug concentrations were measured using a validated LC/MS assay.	Day 78 (predose up to 12 hours postdose)
Change From Baseline in Serum Immunoglobulin G (IgG) at Early Termination Visit (up to Day 141)	Serum concentration of IgG was measured using validated nephelometric assays.	Baseline, early termination visit (up to Day 141)
Percent FcRN Receptor Occupancy at Day 120		Day 120
Number of Participants With Antidrug Antibodies (ADA) and Neutralizing Antibodies (NAb) to ALXN1830		Day 1 (postdose) through follow-up (up to approximately 141 days)

Collaborators and Investigators

• Sponsor: Alexion Pharmaceuticals, Inc.
• Collaborators: Syneos Health

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2021
• Primary Completion (Actual): December 14, 2021
• Study Completion (Actual): January 4, 2022

Study Registration Dates

• First Submitted: January 26, 2021
• First Submitted That Met QC Criteria: January 26, 2021
• First Posted (Actual): January 29, 2021

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 16, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Pharmacodynamics; Autoimmune Disease; ALXN1830
• Other Study ID Numbers: ALXN1830-HV-108; 2020-001081-11 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes