NCT04920370

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Sep 2019

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 4, 2019

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 9, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2021

Completed
Last Updated

February 11, 2022

Status Verified

January 1, 2022

Enrollment Period

2.2 years

First QC Date

June 3, 2021

Last Update Submit

February 2, 2022

Conditions

Healthy

Keywords

ALXN1720SafetyPharmacokineticsPharmacodynamics

Outcome Measures

Primary Outcomes (1)

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

    Up to 176 days following the first day of dosing

Secondary Outcomes (14)

  • 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 Serum Concentrations of Total 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

  • +9 more secondary outcomes

Study Arms (5)

ALXN1720 Single Dose SC

EXPERIMENTAL

Participants will receive a single dose of ALXN1720 SC.

Drug: ALXN1720 SC

ALXN1720 Multiple Dose SC

EXPERIMENTAL

Participants will receive multiple doses of ALXN1720 SC.

Drug: ALXN1720 SC

ALXN1720 Single Dose SC + rHuPH20

EXPERIMENTAL

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

Drug: ALXN1720 SCDrug: rHuPH20

ALXN1720 Single Dose IV

EXPERIMENTAL

Participants will receive a single dose of ALXN1720 IV.

Drug: ALXN1720 IV

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo SCDrug: Placebo IV

Interventions

ALXN1720 SCDRUG

ALXN1720 will be administered via SC route.

ALXN1720 Multiple Dose SCALXN1720 Single Dose SCALXN1720 Single Dose SC + rHuPH20
ALXN1720 IVDRUG

ALXN1720 will be administered via IV route.

ALXN1720 Single Dose IV
rHuPH20DRUG

rHuPH20 will be administered via SC route.

ALXN1720 Single Dose SC + rHuPH20
Placebo SCDRUG

Placebo will be administered via SC route.

Placebo
Placebo IVDRUG

Placebo will be administered via IV route.

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Study Site

London, United Kingdom

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2021

First Posted

June 9, 2021

Study Start

September 4, 2019

Primary Completion

November 16, 2021

Study Completion

November 16, 2021

Last Updated

February 11, 2022

Record last verified: 2022-01

Locations

GB(1)