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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05428696

Enrollment

Registered

2022-06-23

Start date

2022-09-12

Completion date

2023-05-26

Last updated

2024-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

ALXN2080, Complement system, Pharmacokinetics

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.

Interventions

DRUGALXN2080

Powder-in-capsule

DRUGPlacebo

Powder-in-capsule

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026