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

NCT ID: NCT05428696

Last Updated: 2024-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-12
• Study Completion Date: 2023-05-26

Brief Summary

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

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

SAD - Cohort 1

Eight participants will receive a single dose of Dose Amount 1 of ALXN2080, and 2 participants will receive placebo.

Group Type: EXPERIMENTAL

ALXN2080

Intervention Type: DRUG

Powder-in-capsule

Placebo

Intervention Type: DRUG

Powder-in-capsule

SAD - Cohort 2

Eight participants will receive a single dose of Dose Amount 2 of ALXN2080, and 2 participants will receive placebo.

Group Type: EXPERIMENTAL

ALXN2080

Intervention Type: DRUG

Powder-in-capsule

Placebo

Intervention Type: DRUG

Powder-in-capsule

SAD - Cohort 3

Eight participants will receive a single dose of Dose Amount 3 of ALXN2080, and 2 participants will receive placebo.

Group Type: EXPERIMENTAL

ALXN2080

Intervention Type: DRUG

Powder-in-capsule

Placebo

Intervention Type: DRUG

Powder-in-capsule

SAD - Cohort 4

Eight participants will receive a single dose of Dose Amount 4 of ALXN2080, and 2 participants will receive placebo.

Group Type: EXPERIMENTAL

ALXN2080

Intervention Type: DRUG

Powder-in-capsule

Placebo

Intervention Type: DRUG

Powder-in-capsule

SAD - Cohort 5

Eight participants will receive a single dose of Dose Amount 5 of ALXN2080, and 2 participants will receive placebo.

Group Type: EXPERIMENTAL

ALXN2080

Intervention Type: DRUG

Powder-in-capsule

Placebo

Intervention Type: DRUG

Powder-in-capsule

SAD - Cohort 6

Eight participants will receive a single dose of Dose Amount 6 of ALXN2080, and 2 participants will receive placebo.

Group Type: EXPERIMENTAL

ALXN2080

Intervention Type: DRUG

Powder-in-capsule

Placebo

Intervention Type: DRUG

Powder-in-capsule

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.

Group Type: EXPERIMENTAL

ALXN2080

Intervention Type: DRUG

Powder-in-capsule

Placebo

Intervention Type: DRUG

Powder-in-capsule

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.

Group Type: EXPERIMENTAL

ALXN2080

Intervention Type: DRUG

Powder-in-capsule

Placebo

Intervention Type: DRUG

Powder-in-capsule

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.

Group Type: EXPERIMENTAL

ALXN2080

Intervention Type: DRUG

Powder-in-capsule

Placebo

Intervention Type: DRUG

Powder-in-capsule

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.

Group Type: EXPERIMENTAL

ALXN2080

Intervention Type: DRUG

Powder-in-capsule

Placebo

Intervention Type: DRUG

Powder-in-capsule

Interventions

ALXN2080

Powder-in-capsule

Intervention Type: DRUG

Placebo

Powder-in-capsule

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Celerion

INDUSTRY

Sponsor Role: collaborator

Alexion Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Trial Site

Belfast, , United Kingdom

Countries

United Kingdom

Other Identifiers

ALXN2080-HV-101

Identifier Type: -

Identifier Source: org_study_id