Clinical Trials/NCT04920370

NCT04920370

Completed

Phase 1

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study of Subcutaneous and Intravenous ALXN1720 With and Without rHuPH20 in Healthy Subjects

Alexion Pharmaceuticals, Inc.1 site in 1 country97 target enrollmentSeptember 4, 2019

ConditionsHealthy

InterventionsALXN1720 SC rHuPH20 ALXN1720 IV Placebo SC Placebo IV

DrugsALXN1720 SC ALXN1720 IV rHuPH20 Placebo SC Placebo IV

Overview

Phase: Phase 1
Intervention: ALXN1720 SC
Conditions: Healthy
Sponsor: Alexion Pharmaceuticals, Inc.
Enrollment: 97
Locations: 1
Primary Endpoint: Incidence of Treatment-emergent and Serious Adverse Events (TEAEs, SAEs)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of ALXN1720 administered subcutaneously (SC) or intravenously (IV).

Detailed Description

Participants will be randomized in a 3:1 ratio to receive the active treatment or placebo. The study will be conducted in healthy adult participants, including participants of Japanese descent.

Registry

clinicaltrials.gov

Start Date

September 4, 2019

End Date

November 16, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Alexion Pharmaceuticals, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Body weight within 50 to 90 kilograms (kg), inclusive, and body mass index within the range of 18 to 29.9 kg/meter squared, inclusive.
•Willing to follow protocol-specified contraception guidance while on treatment and for 6 months after the last dose of study treatment.
•Vaccination with tetravalent meningococcal conjugate vaccine and serogroup B meningococcal vaccine.
•No clinically significant or relevant abnormalities as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram, and clinical laboratory evaluation.
•For the cohorts with Japanese participants, parents and grandparents must both be Japanese, and participants must have resided for less than 5 years outside of Japan.

Exclusion Criteria

•Current or recurrent disease that could affect clinical assessments or clinical laboratory evaluations.
•History of complement deficiency or complement activity below the reference range.
•Female participants who are breastfeeding.
•Immunization with a live-attenuated vaccine 28 days prior to dosing on Day 1 or planned vaccination during the course of the study. Immunization with inactivated or recombinant influenza vaccine, or nucleoside-modified messenger ribonucleic acid or recombinant COVID-19 vaccine is permitted.
•Current tobacco smoking, history of illicit drug abuse, or history of significant alcohol abuse.

Arms & Interventions

ALXN1720 Single Dose SC + rHuPH20

Participants will receive a single dose of ALXN1720 SC in combination with rHuPH20.

Intervention: ALXN1720 SC

ALXN1720 Single Dose SC

Participants will receive a single dose of ALXN1720 SC.

Intervention: ALXN1720 SC

ALXN1720 Multiple Dose SC

Participants will receive multiple doses of ALXN1720 SC.

Intervention: ALXN1720 SC

ALXN1720 Single Dose SC + rHuPH20

Participants will receive a single dose of ALXN1720 SC in combination with rHuPH20.

Intervention: rHuPH20

ALXN1720 Single Dose IV

Participants will receive a single dose of ALXN1720 IV.

Intervention: ALXN1720 IV

Placebo

Participants will receive Placebo SC or Placebo IV according to their assigned cohort.

Intervention: Placebo SC

Placebo

Participants will receive Placebo SC or Placebo IV according to their assigned cohort.

Intervention: Placebo IV

Outcomes

Primary Outcomes

Incidence of Treatment-emergent and Serious Adverse Events (TEAEs, SAEs)

Time Frame: Up to 176 days following the first day of dosing

Secondary Outcomes

Maximum Observed Concentration (Cmax) of ALXN1720 SC, ALXN1720 SC/rHuPH20, and ALXN1720 IV(Up to 176 days following the first day of dosing)
Area Under The Concentration-time Curve (AUC) of ALXN1720 SC, ALXN1720 SC/rHuPH20, and ALXN1720 IV(Up to 176 days following the first day of dosing)
Change from Baseline in Serum Concentrations of Free Complement Component 5 (C5)(Baseline, 176 days following the first day of dosing)
Change from Baseline in Ex Vivo Chicken Red Blood Cell (cRBC) Hemolysis Activity(Baseline, 176 days following the first day of dosing)
Change from Baseline in Serum Concentrations of Total C5(Baseline, 176 days following the first day of dosing)
Comparison of AUC of ALXN1720 SC, ALXN1720 SC/rHuPH20, and ALXN1720 IV Between Healthy Non-Japanese Participants and Participants of Japanese Descent(Up to 176 days following the first day of dosing)
Comparison of Change from Baseline in Serum Concentrations of Free C5 Between Healthy Non-Japanese Participants and Participants of Japanese Descent(Baseline, 176 days following the first day of dosing)
Comparison of Change from Baseline in Serum Concentrations of Total C5 Between Healthy Non-Japanese Participants and Participants of Japanese Descent(Baseline, 176 days following the first day of dosing)
Incidence of Antidrug Antibodies (ADAs) to ALXN1720(Up to 176 days following the first day of dosing)
Absolute Bioavailability of ALXN1720(Up to 176 days following the first day of dosing)
Comparison of Incidence of TEAEs and SAEs Between Healthy Non-Japanese Participants and Participants of Japanese Descent(Up to 176 days following the first day of dosing)
Comparison of Cmax of ALXN1720 SC, ALXN1720 SC/rHuPH20, and ALXN1720 IV Between Healthy Non-Japanese Participants and Participants of Japanese Descent(Up to 176 days following the first day of dosing)
Comparison of Change from Baseline in Serum Concentrations in Ex Vivo cRBC Hemolysis Activity Between Healthy Non-Japanese Participants and Participants of Japanese Descent(Baseline, 176 days following the first day of dosing)
Comparison of ADAs to ALXN1720 Between Healthy Non-Japanese Participants and Participants of Japanese Descent(Up to 176 days following the first day of dosing)