A Study of Single and Multiple SC Doses 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 study will evaluate the effects of single ascending doses (SAD) and multiple ascending doses (MAD) of ALXN1830 administered subcutaneously (SC) to healthy adult participants.

Study Overview

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

Detailed Description

This Phase 1 study will consist of 3 SAD (Cohorts 1 to 3) and 4 MAD (Cohorts 4 to 7) cohorts. Participants will be randomly assigned in a 6:2 ratio to each of the 7 cohorts to receive either single or multiple doses of ALXN1830 (n = 6 per cohort) or single or multiple doses of placebo (n = 2 per cohort).

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Clinical Trial Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older 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 50 to 90 kg, inclusive, and body mass index (BMI) within the range of 18 to 24.9 kg/m^2, inclusive.
• Must be willing to follow protocol-specified contraception guidance during the study and for up to 3 months after last dose of study drug.

Exclusion Criteria:

• Current/recurrent diseases or relevant medical history.
• Known exposure to therapeutic proteins, such as monoclonal antibodies, including marketed drugs prior to dosing.
• Participants who have prior exposure to ALXN1830.
• Exposure to more than 4 new (small molecule) investigational compounds within 12 months prior to dosing.
• Current enrollment or past participation within the last 90 days before signing of consent in this or any other interventional clinical study.
• Presence of hepatitis B surface antigen (HBsAg) at Screening.
• Positive hepatitis C antibody test result at Screening.
• Positive human immunodeficiency virus (HIV) antibody test at Screening.
• 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

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; Participants will receive a single SC dose of ALXN1830 or placebo (750 mg).	Drug: ALXN1830; ALXN1830 will be administered as SC infusion(s).; Drug: Placebo; Placebo will be administered as SC infusion(s).
Experimental: Cohort 2; Participants will receive a single SC dose of ALXN1830 or placebo (1500 mg).	Drug: ALXN1830; ALXN1830 will be administered as SC infusion(s).; Drug: Placebo; Placebo will be administered as SC infusion(s).
Experimental: Cohort 3; Participants will receive a single SC dose of ALXN1830 or placebo (2250 mg).	Drug: ALXN1830; ALXN1830 will be administered as SC infusion(s).; Drug: Placebo; Placebo will be administered as SC infusion(s).
Experimental: Cohort 4; Participants will receive multiple SC doses of ALXN1830 or placebo (300 mg twice weekly; 8 doses total).	Drug: ALXN1830; ALXN1830 will be administered as SC infusion(s).; Drug: Placebo; Placebo will be administered as SC infusion(s).
Experimental: Cohort 5; Participants will receive multiple SC doses of ALXN1830 or placebo (750 mg once weekly; 12 doses total).	Drug: ALXN1830; ALXN1830 will be administered as SC infusion(s).; Drug: Placebo; Placebo will be administered as SC infusion(s).
Experimental: Cohort 6; Participants will receive multiple SC doses of ALXN1830 or placebo (1500 mg once weekly; 4 doses total).	Drug: ALXN1830; ALXN1830 will be administered as SC infusion(s).; Drug: Placebo; Placebo will be administered as SC infusion(s).
Experimental: Cohort 7; Participants will receive multiple SC doses of ALXN1830 or placebo (2250 mg once weekly; 4 doses total).	Drug: ALXN1830; ALXN1830 will be administered as SC infusion(s).; Drug: Placebo; Placebo will be administered as SC infusion(s).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	A TEAE was defined as any adverse event (AE) that commences after the start of administration of study drug. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. An AE was considered serious if, in the view of the investigator or sponsor, it resulted in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. A summary of all serious AEs and other AEs (nonserious) regardless of causality is located in 'Adverse events' Section.	Baseline up to Day 64

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under The Serum Concentration Versus Time Curve From Time Zero (Dosing) To The Last Quantifiable Concentration (AUC0-t) of ALXN1830		Predose, end of infusion, and 0.5, 2, 4, 8, and 12 hours postdose on Day 1; and Days 2 to 8
Percent Change From Baseline in Immunoglobulin G (IgG) Levels at Day 10		Baseline, Day 10
Number of Participants With Positive Anti-Drug Antibodies (ADA)		Baseline up to Day 64
Number of Participants With Positive Neutralizing Antibodies (NAbs)	All samples that are confirmed positive for ADA were evaluated for the presence of neutralizing antibodies.	Baseline up to Day 64

Collaborators and Investigators

• Sponsor: Alexion Pharmaceuticals, Inc.

Publications and helpful links

Helpful Links

• CSR Synopsis
• Related Info
• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2019
• Primary Completion (Actual): January 22, 2021
• Study Completion (Actual): January 22, 2021

Study Registration Dates

• First Submitted: February 15, 2022
• First Submitted That Met QC Criteria: February 15, 2022
• First Posted (Actual): February 24, 2022

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: ALXN1830-HV-105; 2019-003496-18 (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