Safety and Tolerability, PK, and PD Study of Single and Multiple ALXN2080 Doses in Healthy Participants

June 6, 2024 updated by: Alexion Pharmaceuticals, Inc.

A Randomized, Double-blind, Placebo-controlled First-in-Human Study of Single and Multiple Doses of ALXN2080 in Healthy Participants

This study is designed to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses of ALXN2080 in healthy adult participants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants will be assigned to 10 different cohorts (6 SAD cohorts and 4 MAD cohorts), each with 8 participants on active treatment with ALXN2080 and 2 participants on placebo. ALXN2080 will be administered under fasted conditions throughout this study, except for the last SAD Cohort 6 in which ALXN2080 will be given with food to evaluate the effect of food on the single-dose pharmacokinetics of ALXN2080.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy is defined as having no clinically relevant abnormalities identified by a detailed medical history, physical examination, blood pressure and heart rate measurements, 12-lead ECG, and clinical laboratory tests.
  • Body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg. BMI max is 32 kg/m2.
  • Male or female; female of childbearing potential and male participants agreed to follow protocol specified contraception guidance.

Exclusion Criteria:

  • Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders.
  • History of hypersensitivity to any ingredient contained in the study intervention.
  • Evidence of active infections, history of meningococcal infection, unexplained, or recurrent infection.
  • Known or suspected history of drug or alcohol abuse or dependence.
  • Current tobacco users or smokers.
  • Diseases or conditions or previous procedures known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
  • For females: pregnant, breastfeeding, or intending to conceive during the course of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SAD - Cohort 1
Eight participants will receive a single dose of Dose Amount 1 of ALXN2080, and 2 participants will receive placebo.
Drug: ALXN2080
Powder-in-capsule
Drug: Placebo
Powder-in-capsule
Experimental: SAD - Cohort 2
Eight participants will receive a single dose of Dose Amount 2 of ALXN2080, and 2 participants will receive placebo.
Drug: ALXN2080
Powder-in-capsule
Drug: Placebo
Powder-in-capsule
Experimental: SAD - Cohort 3
Eight participants will receive a single dose of Dose Amount 3 of ALXN2080, and 2 participants will receive placebo.
Drug: ALXN2080
Powder-in-capsule
Drug: Placebo
Powder-in-capsule
Experimental: SAD - Cohort 4
Eight participants will receive a single dose of Dose Amount 4 of ALXN2080, and 2 participants will receive placebo.
Drug: ALXN2080
Powder-in-capsule
Drug: Placebo
Powder-in-capsule
Experimental: SAD - Cohort 5
Eight participants will receive a single dose of Dose Amount 5 of ALXN2080, and 2 participants will receive placebo.
Drug: ALXN2080
Powder-in-capsule
Drug: Placebo
Powder-in-capsule
Experimental: SAD - Cohort 6
Eight participants will receive a single dose of Dose Amount 6 of ALXN2080, and 2 participants will receive placebo.
Drug: ALXN2080
Powder-in-capsule
Drug: Placebo
Powder-in-capsule
Experimental: MAD - Cohort 1
Eight participants will receive multiple doses of Dose Amount A of ALXN2080 at a Dosing Frequency 1, and 2 participants will receive placebo for 14 days.
Drug: ALXN2080
Powder-in-capsule
Drug: Placebo
Powder-in-capsule
Experimental: MAD - Cohort 2
Eight participants will receive multiple doses of Dose Amount B of ALXN2080 at a Dosing Frequency 1, and 2 participants will receive placebo for 14 days.
Drug: ALXN2080
Powder-in-capsule
Drug: Placebo
Powder-in-capsule
Experimental: MAD - Cohort 3
Eight participants will receive multiple doses of Dose Amount C of ALXN2080 at a Dosing Frequency 1 or Frequency 2, and 2 participants will receive placebo for 14 days.
Drug: ALXN2080
Powder-in-capsule
Drug: Placebo
Powder-in-capsule
Experimental: MAD - Cohort 4
Eight participants will receive multiple doses of Dose Amount D of ALXN2080 at a Dosing Frequency 1 or Frequency 2, and 2 participants will receive placebo for 14 days.
Drug: ALXN2080
Powder-in-capsule
Drug: Placebo
Powder-in-capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame: Day 1 through up to Day 28
Day 1 through up to Day 28

Secondary Outcome Measures

Outcome Measure
Time Frame
Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) Of Single Dose ALXN2080
Time Frame: Up to 168 hours postdose
Up to 168 hours postdose
Maximum Observed Plasma Concentration (Cmax) of Single Dose ALXN2080
Time Frame: Up to 168 hours postdose
Up to 168 hours postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexion Pharmaceuticals, Inc.

Collaborators

Celerion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2022

Primary Completion (Actual)

April 24, 2023

Study Completion (Actual)

May 26, 2023

Study Registration Dates

First Submitted

April 26, 2022

First Submitted That Met QC Criteria

June 17, 2022

First Posted (Actual)

June 23, 2022

Study Record Updates

Last Update Posted (Actual)

June 7, 2024

Last Update Submitted That Met QC Criteria

June 6, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ALXN2080-HV-101
  • 2022-000555-36 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on ALXN2080

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe