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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Препарат ALXN2230
  Participants will receive ALXN2230 via SC injection. Optional cohort will receive ALXN2230 via SC infusion.
• Препарат Placebo
  Participants will receive placebo via SC injection. Optional cohort will receive placebo via SC infusion.

Первичные конечные точки

• Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) [Срок оценки: Day 1 up to Day 113]

Вторичные конечные точки (4)

• Maximum Observed Serum Concentration (Cmax) of ALXN2230 [Срок оценки: Day 1 up to Day 113]
• Time to Cmax (Tmax) of ALXN2230 [Срок оценки: Day 1 up to Day 113]
• Area Under the Concentration-time Curve from Time 0 to the Last Quantifiable Concentration (AUCt) of ALXN2230 [Срок оценки: Day 1 up to Day 113]
• Serum Concentration of Biomarkers [Срок оценки: Day 1 up to Day 113]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Фундаментальное исследование

Центры проведения

Великобритания · 1 центр

• Research Site — London

Идентификаторы

NCT: NCT07352423 · R0689C00001 · ALXN2230-HV-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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