Safety and Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ALXN1920 in Healthy Participants

Alexion Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Healthy Participants

Treatments

Biological: Placebo

Biological: ALXN1920

Study type

Interventional

Funder types

Industry

Identifiers

NCT05751642

ALXN1920-HV-101

Details and patient eligibility

About

This study will assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of single ascending doses (SADs) of ALXN1920 subcutaneous (SC) and of a single dose of ALXN1920 intravenous (IV) in healthy adult participants.

Full description

This is a first-in-human study in healthy adult participants.

Eligible participants will be randomly assigned in a 3:1 (ALXN1920:Placebo) ratio in each of the treatment cohorts. The first 2 participants randomized to each cohort will be dosed as a sentinel pair, with 1 participant on active treatment and 1 participant on placebo. At the discretion of the Investigator, up to 3 more participants will be added at least 48 hours after the dosing of the sentinel pair, followed by dosing of the remaining participants in the cohort no earlier than 72 hours after sentinel pair dosing.

The study will comprise:

A Screening Period of up to 28 days; A Dosing Period (single dose through to Follow-up Visit) of approximately 28 days; A Final Follow-up period and end of study Visit is planned on Day 29.

Each participant will be involved in the study for approximately 56 days.

Enrollment

48 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy participants
Body mass index within 18.0 to 32.0 kg/m^2 (inclusive), with a minimum body weight of 50.0 kg.
Female participants of childbearing potential and male participants must follow protocol-specified contraception guidance.
For Cohort 6, participants of Japanese descent, defined as having both parents and 4 grandparents who are ethnically Japanese.

Exclusion criteria

Significant history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders.
History of significant allergic reaction.
History of any Neisseria infection
Active systemic bacterial, viral, or fungal infection.
Participants who at Day -1 are either testing positive for coronavirus disease 2019 (COVID-19), or have not had at least 4 weeks elapse of recovery time (a negative test), or are experiencing long-term COVID-19-related sequelae.
Any major surgery within 8 weeks of Screening.
Known or suspected history of drug or alcohol abuse.
Current tobacco users or smokers.
Positive Human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C viral infection.
Female participant who are pregnant, breastfeeding, or intending to conceive during the course of the study.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Triple Blind

48 participants in 7 patient groups, including a placebo group

Cohort 1

Experimental group

Description: