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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
ALXN2230
DrugParticipants will receive ALXN2230 via SC injection. Optional cohort will receive ALXN2230 via SC infusion.
Placebo
DrugParticipants will receive placebo via SC injection. Optional cohort will receive placebo via SC infusion.
Treatment groups
Trial outcomes
Primary outcomes
Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Secondary outcomes
Maximum Observed Serum Concentration (Cmax) of ALXN2230
Time to Cmax (Tmax) of ALXN2230
Area Under the Concentration-time Curve from Time 0 to the Last Quantifiable Concentration (AUCt) of ALXN2230
Serum Concentration of Biomarkers
Sponsors and contacts
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