Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ALXN2230 in Healthy Participants

Study Identifier:
R0689C00001
ClinicalTrials.gov Identifier:
NCT07352423
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
1-855-752-2356 or [email protected]
Will Be Recruiting

Study Details

Medical Condition
  • Other
Study Drug
  • Drug: ALXN2230
  • Drug: Placebo
Date
Feb 2026 - Dec 2026
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 65 Years
Requirements Information
Inclusion and 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.
Sex
Female & Male
Age
18 - 65 Years

Study Details

Medical Condition
  • Other
Study Drug
  • Drug: ALXN2230
  • Drug: Placebo
Date
Feb 2026 - Dec 2026
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 65 Years years
Requirements Information
Inclusion and 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.

Protocol Summary

The primary objective of this study is to evaluate the safety and tolerability of single subcutaneous (SC) doses of ALXN2230 in healthy participants.

Trial Locations

Location
Status
Location
Research Site
London, United Kingdom, NW10 7EW
Status
N/A