Safety and how the body handles ALXN2230 in healthy adults
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
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.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Alexion Pharmaceuticals, Inc. Industry-sponsored |
| Locations | 1 site (London) |
| Trial ID | NCT07352423 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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). * 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 this trial is running
London
- Research Site — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Alexion Pharmaceuticals, Inc. (Sponsor)
- Email: clinicaltrials@alexion.com
- Phone: 1-855-752-2356
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.