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Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 18 to 65

Safety and how the body handles ALXN2230 in healthy adults

Official title: 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

Run by Alexion Pharmaceuticals, Inc. · NCT07352423 · Data updated 2026-11-12

This test gives single under-the-skin doses of ALXN2230 to healthy adults to see if the medicine is safe and how the body processes and responds to it.

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Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment48 (estimated)
SponsorAlexion Pharmaceuticals, Inc.
Industry-sponsored
Locations1 site (London)
StatusRecruiting
StartedMarch 26, 2026
Main results expectedAugust 9, 2027
Study endsAugust 9, 2027
Registry record updatedNovember 5, 2026
Trial IDNCT07352423 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Healthy non-smoking adults with BMI 18–32 and weight ≥50 kg who meet lab criteria (IgG 1000–1600 mg/dL and tetanus antibody ≥0.1 IU/mL) and have no significant medical conditions.

Probably not a fit

People with active cardiovascular, respiratory, hepatic, renal, neurological, hematological, or other significant medical disorders, smokers, or those seeking direct therapeutic benefit are unlikely to gain clinical benefit from participating.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1, randomized, placebo-controlled study administers single subcutaneous doses of ALXN2230 to healthy adult volunteers to measure safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD). Part A plans to enroll about 40 participants across five cohorts (30 on ALXN2230 and 10 on placebo) and Part B plans about 8 participants in one cohort (6 on ALXN2230 and 2 on placebo). Eligible participants must meet health and lab criteria including specified IgG and tetanus antibody levels, nonsmoking status, and BMI/weight limits. The sponsor is Alexion Pharmaceuticals and the listed research site is in London, with close clinical monitoring and laboratory assessments throughout follow-up.

Why it matters

Potential benefit: If successful, the results would define a safe dose range and how ALXN2230 behaves in the body, guiding future patient trials.

How similar studies have gone: Early-phase single-dose PK/PD trials of similar investigational agents routinely inform dosing and safety for later trials, but ALXN2230 appears to be a novel compound with limited prior human data.

Who can join: the full rules

Show full inclusion / exclusion 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) at screening
* 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 it's running

  • Research Site
    London, United Kingdom     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Healthy Adult Participants 56Alexion Pharmaceuticals, Inc. 20
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.