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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05428696
• Other study ID #: ALXN2080-HV-101
• Secondary ID: 2022-000555-36
• Status: Completed
• Phase: Phase 1
• Start date: September 12, 2022
• Est. completion date: May 26, 2023

Study information

• Verified date: June 2023
• Source: Alexion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 26, 2023
• Est. primary completion date: April 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• ALXN2080
Powder-in-capsule
• Placebo
Powder-in-capsule

Locations

Country	Name	City	State
United Kingdom	Clinical Trial Site	Belfast

Sponsors (2)

Lead Sponsor	Collaborator
Alexion	Celerion

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)		Day 1 through up to Day 28
Secondary	Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) Of Single Dose ALXN2080		Up to 168 hours postdose
Secondary	Maximum Observed Plasma Concentration (Cmax) of Single Dose ALXN2080		Up to 168 hours postdose