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Completed

NCT Number: NCT04631562

Study of ALXN1820 in Healthy Adult Participants

This is a Phase 1, randomized, double-blind, placebo-controlled single and multiple ascending dose study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of ALXN1820 administered subcutaneously (SC) (ALXN1820 SC) and intravenously (IV) (ALXN1820 IV).

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Key information

Conditions

Healthy

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Herston, Australia

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About this study

This study will include up to 10 different dosing cohorts, with each cohort consisting of 2 groups (ALXN1820 group, placebo group). Participants will be randomly assigned in a 3:1 ratio to each of these 2 groups, respectively, within all 10 cohorts, to receive either a single or multiple doses of ALXN1820 SC, a single dose of ALXN1820 IV, or a single or multiple doses of placebo.

The study will be conducted in healthy adult participants and will also include a multiple SC dose cohort in healthy 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 50 to 100 kilograms (kg); body mass index 17 to 32 kg/meter squared.
  • Cohort 9 only: Japanese participants (defined as those participants whose parents and grandparents are both Japanese and who have spent less than 5 years outside of Japan).
  • Satisfactory medical assessment.
  • Must follow protocol-specified contraception guidance while on treatment and for up to 6 months after last dose.
  • Vaccination requirement:
  • Vaccination with tetravalent meningococcal conjugate vaccine at least 56 days and not more than 2 years, 6 months prior to dosing;
  • Vaccination with serogroup B meningococcal vaccine at least 56 days prior to dosing, with a booster at least 28 days prior to dosing, with at least 28 days between the first and second injections.

Exclusion criteria

  • Current/recurrent diseases or relevant medical history.
  • History of any Neisseria infection.
  • Hepatitis B/C, human immunodeficiency virus.
  • History of latent or active tuberculosis (TB), or positive TB test.
  • Active systemic infection within 14 days of dosing.
  • Risk of meningococcal infections due to living/working conditions.
  • History of complement deficiency or complement activity below the reference range.
  • Participation in a clinical study within 90 days or 5 half lives of the investigational agent (whichever is longer) before initiation of dosing on Day 1.
  • Participation in more than 1 clinical study of a monoclonal antibody (mAb), or participation in a clinical study of a mAb within the 6 months or 5 half lives of the mAb (whichever is longer) prior to screening.
  • Acquired complement deficiencies (for example, those receiving eculizumab).

Treatment and study plan

ALXN1820 SC

Drug

ALXN1820 SC will be administered as a manual SC push or SC infusion via a syringe pump. Doses will range from 12.5 milligrams (mg) to a maximum of 2250 mg. Multiple dosing duration will range from 3 to 5 weeks.

ALXN1820 IV

Drug

ALXN1820 IV (450 mg) will be administered as an IV infusion.

Placebo SC

Drug

Placebo SC will be administered as a manual SC push or SC infusion via a syringe pump.

Placebo IV

Drug

Placebo IV will be administered as an IV infusion.

Primary outcomes

  1. Number of Participants With Treatment-related Adverse Events (TEAEs) For ALXN1820 SC And ALXN1820 IV

    Time frame: Cohorts 1 to 6: Baseline up to Day 127; Cohorts 8 to 9: Baseline up to Day 155

    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 any AEs that commenced after the start of administration of study intervention. Serious AEs (SAEs) were defined as any untoward medical occurrence that met at least 1 of the following serious criteria: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, other medically important serious event. A summary of all SAEs and Other AEs (nonserious) regardless of causality is located in the 'Reported AEs' Section.

Secondary outcomes

  1. Area Under The Concentration-time Curve (AUC) From Time 0 (Dosing) To Time Infinity (AUC0-inf) And AUC During The Dosing Interval (AUCtau) of Serum ALXN1820 For Single Dose Cohorts

    Time frame: Up to 126 days following the first day of dosing

  2. Area Under The Concentration-time Curve During The Dosing Interval (AUCtau) Of Serum ALXN1820 For Multiple Dose Cohorts

    Time frame: Up to 154 days following the first day of dosing

  3. Maximum Observed Serum Concentration (Cmax) Of Serum ALXN1820 For Single Dose Cohorts

    Time frame: Up to 126 days following the first day of dosing

  4. Maximum Observed Serum Concentration (Cmax) Of Serum ALXN1820 For Multiple Dose Cohorts

    Time frame: Up to 154 days following the first day of dosing

  5. Change From Baseline in Serum Concentrations Of Total Properdin For ALXN1820 SC And ALXN1820 IV-Single Dose Cohorts

    Time frame: Baseline, Day 127

  6. Change From Baseline in Serum Concentrations Of Free Properdin For ALXN1820 SC And ALXN1820 IV-Single Dose Cohorts

    Time frame: Baseline, Day 127

  7. Change From Baseline In Serum Concentrations of Total Properdin For ALXN1820 SC- Multiple Dose Cohorts

    Time frame: Baseline, Day 155

  8. Change From Baseline In Serum Concentrations of Free Properdin For ALXN1820 SC- Multiple Dose Cohorts

    Time frame: Baseline, Day 155

  9. Change From Baseline In Complement Alternative Pathway (CAP) Activity Using The Wieslab Alternative Pathway (AP) Assay For ALXN1820 SC And ALXN1820 IV-Single Dose Cohorts

    Time frame: Baseline, Day 127

  10. Change From Baseline In Complement Alternative Pathway Activity Using The Wieslab Alternative Pathway Assay For ALXN1820 SC- Multiple Dose Cohorts

    Time frame: Baseline, Day 155

  11. Number Of Participants With Positive Antidrug Antibodies (ADAs) To ALXN1820 SC And ALXN1820 IV

    Time frame: Baseline up to Day 155

  12. Absolute Bioavailability Of ALXN1820 SC

    Time frame: Baseline up to Day 127

    The absolute bioavailability was expressed as ratio and was calculated as the geometric mean for the AUC[0-inf] for SC divided by the geometric mean for the AUC[0-inf] for IV. Least square means were calculated with cohort, treatment, and sequence as the fixed effects, and participant-participant (sequence) as a random effect.

Sponsors and collaborators

Lead sponsor

Alexion Pharmaceuticals, Inc.

Industry

Collaborators

  • Syneos Health

Registry information

Official study title

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study of Subcutaneous and Intravenous ALXN1820 in Healthy Participants

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 17, 2020
Registry last updated
Aug 20, 2024

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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