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

NCT05751642 | Completed Phase 1

• 1 other identifier: ALXN1920-HV-101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Healthy Participants

Keywords

First-in-human; Single ascending dose; Sentinel dosing; ALXN1920; Safety; Pharmacokinetics; Pharmacodynamics; Japanese Descent

Outcome Measures

Primary Outcomes (1)

• Number of participants with Adverse events (AEs)

  To assess the safety and tolerability of single ascending doses of ALXN1920.

  Up to End of study visit (Day 29)

Secondary Outcomes (17)

• Maximum observed concentration (Cmax)

  Day 1 (Pre-dose, 0.5, 1, 2, 6 and 12 hours post-dose), post-dose on Day 2, 3, 4, 5, 6, 8, 15, 22, and 29

• Time to maximum observed concentration (tmax)

  Day 1 (Pre-dose, 0.5, 1, 2, 6 and 12 hours post-dose), post-dose on Day 2, 3, 4, 5, 6, 8, 15, 22, and 29

• Area under the concentration-time curve from time 0 (dosing) to the last quantifiable concentration (AUC0-t)

  Day 1 (Pre-dose, 0.5, 1, 2, 6 and 12 hours post-dose), post-dose on Day 2, 3, 4, 5, 6, 8, 15, 22, and 29

• Area under the concentration-time curve from time 0 (dosing) to time infinity (AUCinf)

  Day 1 (Pre-dose, 0.5, 1, 2, 6 and 12 hours post-dose), post-dose on Day 2, 3, 4, 5, 6, 8, 15, 22, and 29

• Terminal elimination half-life (t½)

  Day 1 (Pre-dose, 0.5, 1, 2, 6 and 12 hours post-dose), post-dose on Day 2, 3, 4, 5, 6, 8, 15, 22, and 29

Study Arms (7)

Cohort 1

EXPERIMENTAL

Participants will receive a single dose of ALXN1920.

Biological: ALXN1920

Cohort 2

EXPERIMENTAL

Participants will receive a single dose of ALXN1920.

Biological: ALXN1920

Cohort 3

EXPERIMENTAL

Participants will receive a single dose of ALXN1920.

Biological: ALXN1920

Cohort 4

EXPERIMENTAL

Participants will receive a single dose of ALXN1920.

Biological: ALXN1920

Cohort 5

EXPERIMENTAL

Participants will receive a single dose of ALXN1920.

Biological: ALXN1920

Cohort 6: Japanese Cohort

EXPERIMENTAL

Japanese participants will receive a single dose of ALXN1920.

Biological: ALXN1920

Pooled Placebo

PLACEBO COMPARATOR

Participants will receive Placebo.

Biological: Placebo

Interventions

ALXN1920 BIOLOGICAL

Participants will receive a single dose of ALXN1920 by Subcutaneous (SC) injection.

Cohort 1; Cohort 2

Placebo BIOLOGICAL

Participants will receive a single dose of Placebo by SC injection, SC infusion or IV infusion.

Pooled Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexion Pharmaceuticals, Inc.: lead

Study Sites (2)

Clinical Trial Site

Grafton, Auckland, 1010, New Zealand

Location

Research Site

Christchurch, 8011, New Zealand

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 2, 2023
• Study Start: April 19, 2023
• Primary Completion: December 4, 2023
• Study Completion: December 4, 2023
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

NZ (2)