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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05254613
• Other study ID #: ALXN1830-HV-105
• Secondary ID: 2019-003496-18
• Status: Terminated
• Phase: Phase 1
• Start date: November 12, 2019
• Est. completion date: January 22, 2021

Study information

• Verified date: March 2024
• Source: Alexion Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: January 22, 2021
• Est. primary completion date: January 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• ALXN1830
ALXN1830 will be administered as SC infusion(s).
• Placebo
Placebo will be administered as SC infusion(s).

Locations

Country	Name	City	State
United Kingdom	Clinical Trial Site	London

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)	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	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
Secondary	Percent Change From Baseline in Immunoglobulin G (IgG) Levels at Day 10		Baseline, Day 10
Secondary	Number of Participants With Positive Anti-Drug Antibodies (ADA)		Baseline up to Day 64
Secondary	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

External Links

•   CSR Synopsis
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