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

NCT05428696 | Completed Phase 1

• 1 other identifier: ALXN2080-HV-101
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

ALXN2080; Complement system; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  Day 1 through up to Day 28

Secondary Outcomes (2)

• Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) Of Single Dose ALXN2080

  Up to 168 hours postdose

• Maximum Observed Plasma Concentration (Cmax) of Single Dose ALXN2080

  Up to 168 hours postdose

Study Arms (10)

SAD - Cohort 1

EXPERIMENTAL

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

Drug: ALXN2080; Drug: Placebo

SAD - Cohort 2

EXPERIMENTAL

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

Drug: ALXN2080; Drug: Placebo

SAD - Cohort 3

EXPERIMENTAL

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

Drug: ALXN2080; Drug: Placebo

SAD - Cohort 4

EXPERIMENTAL

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

Drug: ALXN2080; Drug: Placebo

SAD - Cohort 5

EXPERIMENTAL

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

Drug: ALXN2080; Drug: Placebo

SAD - Cohort 6

EXPERIMENTAL

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

Drug: ALXN2080; Drug: Placebo

MAD - Cohort 1

EXPERIMENTAL

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; Drug: Placebo

MAD - Cohort 2

EXPERIMENTAL

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; Drug: Placebo

MAD - Cohort 3

EXPERIMENTAL

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; Drug: Placebo

MAD - Cohort 4

EXPERIMENTAL

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; Drug: Placebo

Interventions

ALXN2080 DRUG

Powder-in-capsule

MAD - Cohort 1; MAD - Cohort 2; MAD - Cohort 3; MAD - Cohort 4; SAD - Cohort 1; SAD - Cohort 2; SAD - Cohort 3; SAD - Cohort 4; SAD - Cohort 5; SAD - Cohort 6

Placebo DRUG

Powder-in-capsule

MAD - Cohort 1; MAD - Cohort 2; MAD - Cohort 3; MAD - Cohort 4; SAD - Cohort 1; SAD - Cohort 2; SAD - Cohort 3; SAD - Cohort 4; SAD - Cohort 5; SAD - Cohort 6

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexion Pharmaceuticals, Inc.: lead
• Celerion: collaborator

Study Sites (1)

Clinical Trial Site

Belfast, BT9 6AD, United Kingdom

Location

Study Design

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

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: June 23, 2022
• Study Start: September 12, 2022
• Primary Completion: April 24, 2023
• Study Completion: May 26, 2023
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)