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Looking for participantsPhase1

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

Sponsor: Alexion Pharmaceuticals, Inc.

NCT ID: NCT07352423

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
ALXN2230 (drug), Placebo (drug)
How long the study runs
Study runs about 9 months (dates as stated)
About the drug or intervention
ALXN2230 — drug: Participants will receive ALXN2230 via SC injection. · Placebo — drug: Participants will receive placebo via SC injection.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 65 Years
Who
All
Number of participants
48
Started
2026-03-26
Last checked
2026-04

Plain English Summary

What is this study?

  • • Testing a new treatment for healthy adult participants
  • • Phase1 - 48 participants
  • • The primary objective of this study is to evaluate the safety and tolerability of single subcutaneous (SC) doses of ALXN2230 in healthy participants

Who can take part?

  • • Ages 18 Years to 65 Years
  • • Diagnosed with healthy adult participants

Where?

  • • London - Research Site

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

More detail

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.

Healthy Adult Participants

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 65 Years
  • Who can join: All genders

What the study is looking for

  • ✓Participants who are overtly healthy as determined by medical evaluation including medical history, physical...
  • ✓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...
  • ✓BMI within the range 18 to 32 kilograms per square meter (kg/m2), inclusive; with body weight ≥ 50 kilograms (kg).

Who cannot take part

  • ✗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...
  • ✗Pregnant or breastfeeding females are excluded from the clinical study.
  • ✗Participants with known clinically relevant immunological disorders.
See the full criteria
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.

Where Is This Study? (1 UK site)

Research Site

London NW10 7EW, United Kingdom

Recruiting

How to Get in Touch

Alexion Pharmaceuticals, Inc. (Sponsor)

Sponsor contact

CONTACT

1-855-752-2356 clinicaltrials@alexion.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-04