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OpenTrials
Completed

NCT Number: NCT04920370

Study of Subcutaneous and Intravenous ALXN1720 With and Without rHuPH20 in Healthy Subjects

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

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Study Site

London, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ALXN1720 SC

Drug

ALXN1720 will be administered via SC route.

ALXN1720 IV

Drug

ALXN1720 will be administered via IV route.

rHuPH20

Drug

rHuPH20 will be administered via SC route.

Placebo SC

Drug

Placebo will be administered via SC route.

Placebo IV

Drug

Placebo will be administered via IV route.

Primary outcomes

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

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

Secondary outcomes

  1. Maximum Observed Concentration (Cmax) of ALXN1720 SC, ALXN1720 SC/rHuPH20, and ALXN1720 IV

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

  2. Area Under The Concentration-time Curve (AUC) of ALXN1720 SC, ALXN1720 SC/rHuPH20, and ALXN1720 IV

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

  3. Change from Baseline in Serum Concentrations of Free Complement Component 5 (C5)

    Time frame: Baseline, 176 days following the first day of dosing

  4. Change from Baseline in Serum Concentrations of Total C5

    Time frame: Baseline, 176 days following the first day of dosing

  5. Change from Baseline in Ex Vivo Chicken Red Blood Cell (cRBC) Hemolysis Activity

    Time frame: Baseline, 176 days following the first day of dosing

  6. Incidence of Antidrug Antibodies (ADAs) to ALXN1720

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

  7. Absolute Bioavailability of ALXN1720

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

    The absolute bioavailability for ALXN1720 SC will be defined by the ratio of the geometric means for AUC for ALXN1720 SC over ALXN1720 IV after a single dose.

  8. Comparison of Incidence of TEAEs and SAEs Between Healthy Non-Japanese Participants and Participants of Japanese Descent

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

  9. Comparison of Cmax of ALXN1720 SC, ALXN1720 SC/rHuPH20, and ALXN1720 IV Between Healthy Non-Japanese Participants and Participants of Japanese Descent

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

  10. Comparison of AUC of ALXN1720 SC, ALXN1720 SC/rHuPH20, and ALXN1720 IV Between Healthy Non-Japanese Participants and Participants of Japanese Descent

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

  11. Comparison of Change from Baseline in Serum Concentrations of Free C5 Between Healthy Non-Japanese Participants and Participants of Japanese Descent

    Time frame: Baseline, 176 days following the first day of dosing

  12. Comparison of Change from Baseline in Serum Concentrations of Total C5 Between Healthy Non-Japanese Participants and Participants of Japanese Descent

    Time frame: Baseline, 176 days following the first day of dosing

  13. Comparison of Change from Baseline in Serum Concentrations in Ex Vivo cRBC Hemolysis Activity Between Healthy Non-Japanese Participants and Participants of Japanese Descent

    Time frame: Baseline, 176 days following the first day of dosing

  14. Comparison of ADAs to ALXN1720 Between Healthy Non-Japanese Participants and Participants of Japanese Descent

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

Sponsors and collaborators

Lead sponsor

Alexion Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 9, 2021
Registry last updated
Feb 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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