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

NCT05254613 | Terminated Phase 1 Results FDA Drug

• 2 other identifiers: ALXN1830-HV-1052019-003496-18
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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)

  Baseline up to Day 64

Study Arms (7)

Cohort 1

EXPERIMENTAL

Participants will receive a single SC dose of ALXN1830 or placebo (750 mg).

Drug: ALXN1830; Drug: Placebo

Cohort 2

EXPERIMENTAL

Participants will receive a single SC dose of ALXN1830 or placebo (1500 mg).

Drug: ALXN1830; Drug: Placebo

Cohort 3

EXPERIMENTAL

Participants will receive a single SC dose of ALXN1830 or placebo (2250 mg).

Drug: ALXN1830; Drug: Placebo

Cohort 4

EXPERIMENTAL

Participants will receive multiple SC doses of ALXN1830 or placebo (300 mg twice weekly; 8 doses total).

Drug: ALXN1830; Drug: Placebo

Cohort 5

EXPERIMENTAL

Participants will receive multiple SC doses of ALXN1830 or placebo (750 mg once weekly; 12 doses total).

Drug: ALXN1830; Drug: Placebo

Cohort 6

EXPERIMENTAL

Participants will receive multiple SC doses of ALXN1830 or placebo (1500 mg once weekly; 4 doses total).

Drug: ALXN1830; Drug: Placebo

Cohort 7

EXPERIMENTAL

Participants will receive multiple SC doses of ALXN1830 or placebo (2250 mg once weekly; 4 doses total).

Drug: ALXN1830; Drug: Placebo

Interventions

ALXN1830 DRUG

ALXN1830 will be administered as SC infusion(s).

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6; Cohort 7

Placebo DRUG

Placebo will be administered as SC infusion(s).

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6; Cohort 7

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexion Pharmaceuticals, Inc.: lead

Study Sites (1)

Clinical Trial Site

London, United Kingdom

Location

Related Links

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

Limitations and Caveats

The study was terminated early due to a lack of participant availability caused by COVID-19 pandemic after completion of the ALXN1830 750 mg dose group and partial enrollment of the ALXN1830 1250 mg dose group.

Results Point of Contact

• Title: Alexion Pharmaceuticals Inc.
• Organization: Alexion Pharmaceuticals Inc.

clinicaltrials@alexion.com

+1 855-752-2356

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: February 24, 2022
• Study Start: November 12, 2019
• Primary Completion: January 22, 2021
• Study Completion: January 22, 2021
• Last Updated: March 22, 2024
• Results First Posted: March 22, 2024

Record last verified: 2024-03

Locations

GB (1)