A Study of a Single Dose of ALXN1210 in Healthy Participants

NCT05288660 | Completed Phase 1 Results FDA Drug

• 1 other identifier: ALXN1210-HV-101
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluated the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a single dose of ALXN1210 in healthy participants, as assessed by electrocardiograms, physical examination, vital signs, laboratory analysis, and assessment of adverse events (AEs).

Conditions

Healthy

Keywords

ALXN1210; Pharmacokinetic; Pharmacodynamic; Safety; Immunogenicity

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline up to Day 150

Secondary Outcomes (15)

• Maximum Observed Serum Concentration (Cmax) of ALXN1210

  Predose, 30 minutes, 4, 8, 24, 48, 96 hours postdose, then at Days 8, 15, 22, 29, 36, 43, 50, 57, 71, 90, 120 and 150

• Time To Maximum Observed Serum Concentration (Tmax) of ALXN1210

  Predose, 30 minutes, 4, 8, 24, 48, 96 hours postdose, then at Days 8, 15, 22, 29, 36, 43, 50, 57, 71, 90, 120 and 150

• Area Under The Serum Concentration Versus Time Curve From Time Zero To The Time of The Last Quantifiable Concentration (AUC0-t) of ALXN1210

  Predose, 30 minutes, 4, 8, 24, 48, 96 hours postdose, then at Days 8, 15, 22, 29, 36, 43, 50, 57, 71, 90, 120 and 150

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

  Predose, 30 minutes, 4, 8, 24, 48, 96 hours postdose, then at Days 8, 15, 22, 29, 36, 43, 50, 57, 71, 90, 120 and 150

• Terminal Elimination Rate Constant (λz) of Serum ALXN1210

  Predose, 30 minutes, 4, 8, 24, 48, 96 hours postdose, then at Days 8, 15, 22, 29, 36, 43, 50, 57, 71, 90, 120 and 150

Study Arms (3)

ALXN1210 200 mg

EXPERIMENTAL

ALXN1210 was administered intravenously.

Drug: ALXN1210

ALXN1210 400 mg

EXPERIMENTAL

ALXN1210 was administered intravenously.

Drug: ALXN1210

Placebo

PLACEBO COMPARATOR

Placebo was administered intravenously.

Drug: Placebo

Interventions

ALXN1210 DRUG

All doses of ALXN1210 were administered by IV infusion, using programmable IV infusion pump and IV sets with in-line filters, at a fixed rate of 686 mg/hour (equivalent to 137 milliliters \[mL\]/hour), excluding interruption for safety or technical reason.

Also known as: Ultomiris, Ravulizumab

ALXN1210 200 mg; ALXN1210 400 mg

Placebo DRUG

All doses of placebo were administered by IV infusion, using programmable IV infusion pump and IV sets with in-line filters, at a fixed rate of 686 mg/hour (equivalent to 137 mL/hour), excluding interruption for safety or technical reason.

Placebo

Eligibility Criteria

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

You may qualify if:

• Body mass index from 18 through 29.9 kilogram (kg)/square meter, inclusive, and weight between 50 and 100 kg, inclusive.
• QT interval (Fridericia's correction); ≤450 milliseconds (msec) for males and ≤470 msec for females at screening and pre-dose on Day 1.
• Willing and able to give written informed consent and comply with the study visit schedule.
• Male participant and his female spouse/partner who was of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control (at least 1 of which must be a barrier method), starting at screening and continuing until at least 5 months after the last dose of ALXN1210.
• Documented vaccination with meningococcal conjugate vaccine (MCV4) at least 14 days and not more than 3 years prior to dosing.

You may not qualify if:

• Participants in intimate and prolonged contact (defined as living under the same roof or providing personal care) with individuals who are either immunocompromised, or with a specific underlying medical conditions (anatomic or functional asplenia \[including sickle cell disease\]; congenital complement, properdin, factor D, or primary antibody deficiencies; acquired complement deficiencies \[for example, those receiving eculizumab\]; and human immunodeficiency virus \[HIV\]), people younger than 2 years old and older than 65 years old, and professionals exposed to environments of greater risk for meningococcal disease (research, industrial, and clinical laboratory personnel who are routinely exposed to Neisseria meningitidis, military personnel during recruit training \[military personnel may be at increased risk when accommodated in close quarters\], daycare center workers, or those living on a college or university campus).
• Participants living or working in the Saguenay-Lac-St-Jean area (due to increased incidence of meningococcal infections in that specific area).
• Female participants of childbearing potential, including any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), or who was pregnant, breastfeeding, or was not postmenopausal.
• Positive serum pregnancy test at screening or Day -1.
• Serum creatinine greater than the upper limit of normal (ULN) of the testing laboratory at screening and Day -1.
• Alanine aminotransferase or aspartate aminotransferase \>ULN of the testing laboratory at screening and Day -1.
• Any of the following hematology tests: hemoglobin \<135 grams (g)/L for males and \<120 g/L for females; hematocrit \<0.41 L/L for males and \<0.36 L/L for females; white blood cells \<3.5\*10\^3/microliter (μL) or \>ULN of the testing laboratory; absolute neutrophils \<1.5\*10\^3/μL (\<1.0\*10\^3/μL for black race volunteers) or \>ULN of the testing laboratory; and platelets \<the lower limit of normal of the testing laboratory or \>450\*10\^3/μL at screening and Day -1.
• HIV infection (evidenced by HIV-1 or HIV-2 antibody titer).
• Acute or chronic hepatitis B virus (HBV) infection (evidenced by the presence of HBV surface antigen or immunoglobulin M antibodies against HBV core antigen).
• Acute or chronic hepatitis C virus infection (evidenced by antibody titer).
• Active systemic bacterial, viral, or fungal infection within 14 days prior to dosing.
• Positive QuantiFERON-TB test, indicating possible tuberculosis (TB) infection.
• History of complement deficiency.
• History of malignancy other than basal cell carcinoma.
• Participated in a clinical trial within 30 days before initiation of dosing on Day 1, or used any experimental small-molecule therapy within 30 days prior to dosing on Day 1, or biologic therapy within 90 days prior to initiation of dosing on Day 1 or within 5 half-lives of the product, whichever is greater.

Sponsors & Collaborators

• Alexion Pharmaceuticals, Inc.: lead

Study Sites (1)

Clinical Trial Site

Montreal, Canada

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: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participants and on-site medical/nursing staff at the study site were blinded to study drug/dose assignment. The pharmacy staff preparing the investigational products, however, were not blinded to ALXN1210 study drug assignment, but all other site staff, including the Investigator, were blinded. Sponsor staff was unblinded as needed (for example, to participate in the Safety Review Committee and to determine reportability of serious adverse events \[AEs\]), but was to refrain from sharing any information on study drug assignment with the site staff.
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: March 21, 2022
• Study Start: August 27, 2014
• Primary Completion: March 13, 2015
• Study Completion: March 13, 2015
• Last Updated: May 9, 2023
• Results First Posted: May 9, 2023

Record last verified: 2022-06

Data Sharing

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

Locations

CA (1)