A Study of Single and Multiple SC Doses of ALXN1830 in Healthy Adult Participants

March 20, 2024 updated by: Alexion Pharmaceuticals, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time Frame: Baseline up to Day 64
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: Predose, end of infusion, and 0.5, 2, 4, 8, and 12 hours postdose on Day 1; and Days 2 to 8
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
Time Frame: Baseline, Day 10
Baseline, Day 10
Number of Participants With Positive Anti-Drug Antibodies (ADA)
Time Frame: Baseline up to Day 64
Baseline up to Day 64
Number of Participants With Positive Neutralizing Antibodies (NAbs)
Time Frame: Baseline up to Day 64
All samples that are confirmed positive for ADA were evaluated for the presence of neutralizing antibodies.
Baseline up to Day 64

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alexion Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 12, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 22, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 22, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 15, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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