Actively Recruiting
Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ALXN2230 in Healthy Participants
Led by Alexion Pharmaceuticals, Inc. · Updated on 2026-04-09
48
Participants Needed
1
Research Sites
38 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of this study is to evaluate the safety and tolerability of single subcutaneous (SC) doses of ALXN2230 in healthy participants.
CONDITIONS
Official Title
Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ALXN2230 in Healthy Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 mg/dL and 1600 mg/dL at Screening
- Antibody titers for Tetanus toxoid 0.1 IU/mL at Screening
- Nonsmokers and not using any nicotine-containing products for at least 1 year prior to Screening
- BMI within the range 18 to 32 kg/m2, inclusive; with body weight 50 kg
You will not qualify if you...
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders that affect drug absorption, metabolism, elimination, or pose risk
- Abnormal resting blood pressure exceeding 140/80 mmHg or below 90/60 mmHg
- History of allergy or hypersensitivity to excipients in ALXN2230
- History of unexplained or recurrent infections or infections treated with systemic antibiotics within 90 days prior to dosing
- Pregnant or breastfeeding females
- Known clinically relevant immunological disorders
- History of lymphoma, leukemia, breast cancer, or any malignancy within past 5 years except for certain skin cancers fully resected without metastasis
- ALT above 1.0 times upper limit of normal
- TBIL above 1.0 times upper limit of normal
- Current or chronic liver disease or hepatic/biliary abnormalities except Gilbert's syndrome
- QTc interval above 450 msec for males or 470 msec for females
- Significant blood loss (>500 mL) or blood transfusion within 12 weeks prior to dosing or planned within 4 weeks after study end
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Research Site
London, United Kingdom, NW10 7EW
Actively Recruiting
Research Team
A
Alexion Pharmaceuticals, Inc. (Sponsor)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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