A Study of Single and Multiple Doses of ALXN1210 in Healthy, Adult Japanese Participants

NCT05288816 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: ALXN1210-HV-1042015-005468-40
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluated the safety and tolerability of single and multiple doses (400 and 800 milligrams \[mg\]) of ALXN1210 following intravenous administration to healthy Japanese participants.

Conditions

Healthy

Keywords

ALXN1210; Pharmacokinetics; Pharmacodynamics; Safety; Immunogenicity

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  An adverse event (AE) was defined as any unfavorable and unintended sign (for example, including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or procedure, whether or not considered related to the medicinal product or procedure, which occurred during the course of the clinical study. TEAEs were defined as AEs that occurred on or after the date and time of study drug administration, or those that first occurred before dosing but worsened in frequency or severity after study drug administration. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

  Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298

Secondary Outcomes (11)

• Number of Participants With Anti-Drug Antibodies (ADAs) To ALXN1210

  Cohort 1: Baseline up to Day 120; Cohort 2: Baseline up to Day 140; Cohort 3: Baseline up to Day 298

• Area Under The Serum Concentration Versus Time Curve From Time Zero To Infinity (AUCinf) For Single Dose of ALXN1210

  Cohort 1: Baseline (pre-dose) up to Day 120; Cohort 2: Baseline (pre-dose) up to Day 140

• Area Under The Serum Concentration Versus Time Curve From Time Zero To Infinity (AUCinf) For Multiple Dose of ALXN1210

  Day 113 (pre-dose) up to Day 298

• Maximum Observed Serum Concentration (Cmax) For Single Dose of ALXN1210

  Cohort 1: Baseline (pre-dose) up to Day 120; Cohort 2: Baseline (pre-dose) up to Day 140

• Maximum Observed Serum Concentration (Cmax) For Multiple Dose of ALXN1210

  Day 113 (pre-dose) up to Day 298

Study Arms (3)

Cohort 1: ALXN1210 400 mg (Single)

EXPERIMENTAL

A single dose of ALXN1210 was administered intravenously.

Drug: ALXN1210

Cohort 2: ALXN1210 800 mg (Single)

EXPERIMENTAL

A single dose of ALXN1210 was administered intravenously.

Drug: ALXN1210

Cohort 3: ALXN1210 800 mg (Multiple)

EXPERIMENTAL

ALXN1210 (800 mg) was administered intravenously every 4 weeks for a total of 5 doses.

Drug: ALXN1210

Interventions

ALXN1210 DRUG

Participants received a single dose (400 mg or 800 mg) and multiple doses (800 mg) of ALXN1210.

Also known as: Ultomiris, Ravulizumab

Cohort 1: ALXN1210 400 mg (Single); Cohort 2: ALXN1210 800 mg (Single); Cohort 3: ALXN1210 800 mg (Multiple)

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Japanese males or females aged 25 through 55 years, inclusive (participants who lived outside of Japan for ≤ 10 years and were first-generation Japanese, defined as born in Japan and having 4 biological grandparents who were ethnic Japanese).
• Body mass index from 18 through 29.9 kilogram/square meter (kg/m\^2), inclusive, with weight between 50 and 100 kg, inclusive.
• QT interval (corrected using the Fridericia's formula) ≤ 450 milliseconds (msec) for males and ≤ 470 msec for females at Screening and prior to dosing on Day 1.
• Willing and able to give written informed consent and comply with the study visit schedule
• Documented vaccination with tetravalent meningococcal conjugate vaccine (MCV4) at least 56 days and not more than 3 years prior to dosing. Documentation included a positive serum bactericidal assay to confirm an immune response before study drug administration.
• Vaccination with serogroup B meningococcal vaccine at least 56 days prior to dosing on Day 1, with a booster administered at least 28 days prior to dosing on Day 1, with at least 28 days between the first and second injections.
• Female participants of childbearing potential were required to use highly effective contraception, starting at Screening and continuing until at least 6 months (Cohort 1) or 8 months (Cohorts 2 and 3) after the last dose of ALXN1210.
• Male participants with a female spouse/partner of childbearing potential or a pregnant or breastfeeding spouse or partner had to agree to use barrier contraception during the treatment period and for at least 6 months (Cohort 1) or 8 months (Cohorts 2 and 3) after the last dose of ALXN1210.

You may not qualify if:

• Participants who were in intimate and prolonged contact with (defined as living under the same roof or providing personal care) people younger than 2 years of age or older than 65 years of age, or who were either immunocompromised or had one of the following underlying medical conditions: anatomic or functional asplenia (including sickle cell disease); congenital complement, properdin, factor D, or primary antibody deficiencies; acquired complement deficiencies (for example, those receiving eculizumab); or human immunodeficiency virus (HIV).
• Participants who were professionals exposed to environments of greater risk for meningococcal disease; research, industrial, and clinical laboratory personnel routinely exposed to Neisseria meningitidis; military personnel during recruit training (military personnel may be at increased risk of meningococcal infection when accommodated in close quarters); daycare center workers; those who lived on a college or university campus; and those who planned to travel during the course of the study or have travelled to endemic areas for meningococcal meningitis (for example, India, Sub-Saharan Africa, pilgrimage to Saudi Arabia for Hajj) 6 months prior to dosing.
• History of any Neisseria infection
• History of unexplained, recurrent infection; or infection requiring treatment with systemic antibiotics within the 90 days prior to dosing.
• HIV infection (evidenced by HIV-1 or HIV-2 antibody titer)
• Acute or chronic hepatitis B virus infection. Hepatitis B surface antigen (HBsAg) testing was required for all participants prior to enrollment. Participants with positive HBsAg were not enrolled. For participants with negative HBsAg, the following testing algorithms were required: If hepatitis B core antibody (HBcAb) was negative, the participants was eligible to enroll and If HBcAb was positive, the hepatitis B surface antibody (HBsAb) was tested. (If both HBcAb and HBsAb were positive, the participants was eligible to enroll and If HBcAb was positive and HBsAb was negative, the participants was not enrolled.)
• Acute or chronic hepatitis C virus infection (evidenced by antibody titer)
• Active systemic viral or fungal infection 14 days prior to dosing.
• Positive or indeterminate QuantiFERON-TB test indicating possible tuberculosis infection.
• History of latent or active tuberculosis or exposure to endemic areas within 8 weeks prior to the Screening Visit.
• Female participants who were breastfeeding or were unwilling to practice contraception and were not postmenopausal.
• Positive serum pregnancy test at Screening or Day -1.
• Serum creatinine greater than the upper limit of normal (ULN) of the reference range of the testing laboratory at Screening or Day -1.
• Alanine aminotransferase or aspartate aminotransferase \> ULN of the reference range of the testing laboratory at Screening or \> 1.5\*ULN of the reference range of the testing laboratory at Day -1.
• Any of the following hematology results: hemoglobin \< 130 grams (g)/L for males and \< 115 g/L for females; hematocrit \< 0.37 L/L for males and \< 0.33 L/L for females; white blood cells \< 3.0\*10\^3/microliter (μL); absolute neutrophils \< 2.0\*10\^3/μL; and platelets \< 150 or \> 400\*10\^3/μL at Screening or Day -1; or complete blood count clinical laboratory results that were considered clinically relevant and unacceptable by the investigator at Day -1.

Sponsors & Collaborators

• Alexion Pharmaceuticals, Inc.: lead

Study Sites (1)

Clinical Trial Site

London, United Kingdom

Location

MeSH Terms

Interventions

ravulizumab

Results Point of Contact

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

clinicaltrials@alexion.com

855-752-2356

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: March 21, 2022
• Study Start: April 18, 2016
• Primary Completion: July 5, 2017
• Study Completion: July 5, 2017
• Last Updated: February 5, 2024
• Results First Posted: February 5, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

GB (1)