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

Official title

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

Overview

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

Detailed 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.

Interventions

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

Primary outcome measures

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

Secondary outcome measures (4)

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

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Basic science

Study locations

United Kingdom · 1 center

• Research Site — London

Identifiers

NCT: NCT07352423 · R0689C00001 · ALXN2230-HV-101

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗