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Study of ALXN1820 in Healthy Adult Participants

NCT04631562 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2024-08-20

Study results available
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Summary

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).

Conditions

  • Healthy

Interventions

DRUG

ALXN1820 SC

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.

DRUG

ALXN1820 IV

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

DRUG

Placebo SC

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

DRUG

Placebo IV

Placebo IV will be administered as an IV infusion.

Sponsors & Collaborators

  • Syneos Health

    collaborator OTHER

  • Alexion Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-13
Primary Completion
2022-09-01
Completion
2022-09-01

Countries

  • Australia
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04631562 on ClinicalTrials.gov