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

Alexion Pharmaceuticals

Status and phase: Begins enrollment this month; Phase 1

Conditions: Healthy Adult Participants

Treatments: Drug: Placebo; Drug: ALXN2230

Study type: Interventional

Funder types: Industry

Identifiers

NCT07352423

ALXN2230-HV-101 (Registry Identifier)

R0689C00001

Details and patient eligibility

About

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

Full description

Part A of this study is expected to enroll approximately 40 participants (30 on ALXN2230 and 10 on placebo) across 5 cohorts and Part B is expected to enroll approximately 8 participants (6 on ALXN2230 and 2 on placebo) in 1 cohort.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants will be enrolled across multiple cohorts and will receive a single dose of placebo.

Treatment:

Drug: Placebo

ALXN2230

Experimental group

Description:

Participants will be enrolled across multiple cohorts and will receive a single dose of ALXN2230.

Treatment:

Drug: ALXN2230