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New drug ALXN2230 gets first human safety check

NCT ID NCT07352423

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a single dose of ALXN2230 in 48 healthy adults to see if it is safe and how the body processes it. Participants receive either the drug or a placebo by injection. The goal is to check for side effects and measure drug levels in the blood.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ALXN2230
What could go wrong
This is a very early, small study in healthy people, not patients. It only checks safety and how the drug moves in the body. There is no guarantee it will work for any disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 48 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Research Site

    RECRUITING

    London, NW10 7EW, United Kingdom

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