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

NCT07352423 | Recruiting Phase 1

• 2 other identifiers: R0689C00001ALXN2230-HV-101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Adult Participants

Keywords

ALXN2230; Healthy Participants; Pharmacodynamics; Pharmacokinetics; PK; PD; Immunogenicity; First in Human; Single Ascending Dose

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

  Day 1 up to Day 113

Secondary Outcomes (4)

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants will be enrolled across multiple cohorts and will receive a single dose of placebo.

Drug: Placebo

ALXN2230

EXPERIMENTAL

Participants will be enrolled across multiple cohorts and will receive a single dose of ALXN2230.

Drug: ALXN2230

Interventions

ALXN2230 DRUG

Participants will receive ALXN2230 via SC injection. Optional cohort will receive ALXN2230 via SC infusion.

ALXN2230

Placebo DRUG

Participants will receive placebo via SC injection. Optional cohort will receive placebo via SC infusion.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexion Pharmaceuticals, Inc.: lead

Study Sites (1)

Research Site

London, NW10 7EW, United Kingdom

RECRUITING

Central Study Contacts

Alexion Pharmaceuticals, Inc. (Sponsor)

CONTACT

1-855-752-2356; clinicaltrials@alexion.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 20, 2026
• Study Start: March 26, 2026
• Primary Completion (Estimated): December 23, 2026
• Study Completion (Estimated): December 23, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

GB (1)