Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ALXN2230 in Healthy Participants

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of ALXN2230 in Healthy Adult Participants

The primary objective of this study is to evaluate the safety and tolerability of single subcutaneous (SC) doses of ALXN2230 in healthy participants.

Study Overview

• Status: Recruiting
• Conditions: Healthy Adult Participants
• Intervention / Treatment: Drug: Placebo; Drug: ALXN2230

Detailed Description

Part A of this study is expected to enroll approximately 40 participants (30 on ALXN2230 and 10 on placebo) across 5 cohorts and Part B is expected to enroll approximately 8 participants (6 on ALXN2230 and 2 on placebo) in 1 cohort.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Alexion Pharmaceuticals, Inc. (Sponsor); Phone Number: 1-855-752-2356; Email: clinicaltrials@alexion.com

Study Locations

• United Kingdom
  • London, United Kingdom, NW10 7EW
    • Recruiting
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
• Baseline immunoglobulin G (IgG) concentrations ≥ 1000 milligrams per deciliter (mg/dL) and ≤ 1600 mg/dL at Screening.
• Antibody titers for Tetanus toxoid (≥ 0.1 International Units per milliliter (IU/mL)) at Screening.
• Nonsmokers and not using any nicotine-containing products. A nonsmoker is defined as an individual who has abstained from smoking for at least 1 year prior to Screening.
• BMI within the range 18 to 32 kilograms per square meter (kg/m2), inclusive; with body weight ≥ 50 kilograms (kg).

Exclusion Criteria:

• History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
• Abnormal blood pressure (BP) (resting BP not to exceed 140/80 mmHg and no less than 90/60 mmHg).
• Participants who have history of allergy or hypersensitivity to excipients in ALXN2230.
• History of unexplained, recurrent infection, or infection requiring treatment with systemic antibiotics within 90 days prior to dosing on Day 1.
• Pregnant or breastfeeding females are excluded from the clinical study.
• Participants with known clinically relevant immunological disorders.
• Lymphoma, leukemia, breast cancer or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 5 years.
• ALT > 1.0 × upper limit of normal (ULN)
• TBIL > 1.0 × ULN
• Current or chronic history of liver disease or known hepatic or biliary abnormalities (with exception for Gilbert's syndrome).
• QTc > 450 millisecond (msec) for male participants or > 470 msec for female participants.
• Significant blood loss (including blood donation [> 500 mL]) or had a transfusion of any blood product within 12 weeks prior to dosing or plan 1 within 4 weeks after the end of the study.

Additional inclusion/exclusion criteria may apply, per protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants will be enrolled across multiple cohorts and will receive a single dose of placebo.	Drug: Placebo; Participants will receive placebo via SC injection. Optional cohort will receive placebo via SC infusion.
Experimental: ALXN2230; Participants will be enrolled across multiple cohorts and will receive a single dose of ALXN2230.	Drug: ALXN2230; Participants will receive ALXN2230 via SC injection. Optional cohort will receive ALXN2230 via SC infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)	Day 1 up to Day 113

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum Observed Serum Concentration (Cmax) of ALXN2230	Day 1 up to Day 113
Time to Cmax (Tmax) of ALXN2230	Day 1 up to Day 113
Area Under the Concentration-time Curve from Time 0 to the Last Quantifiable Concentration (AUCt) of ALXN2230	Day 1 up to Day 113
Serum Concentration of Biomarkers	Day 1 up to Day 113

Collaborators and Investigators

• Sponsor: Alexion Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2026
• Primary Completion (Estimated): December 23, 2026
• Study Completion (Estimated): December 23, 2026

Study Registration Dates

• First Submitted: January 12, 2026
• First Submitted That Met QC Criteria: January 12, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Pharmacokinetics; PK; Immunogenicity; Healthy Participants; First in Human; Pharmacodynamics; PD; Single Ascending Dose; ALXN2230
• Other Study ID Numbers: R0689C00001; ALXN2230-HV-101 (Registry Identifier: Alexion)

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 CSR synopsis and plain language summaries.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No