An Open-Label, Randomized, Single-Dose, Multicenter, Parallel-Group Study to Compare the Pharmacokinetics of Subcutaneous Depemokimab When Delivered With a Safety Syringe Device or an Autoinjector in Healthy Adult Participants

214099

This study will compare the pharmacokinetics, safety, tolerability, and immunogenicity of Depemokimab administered via a SSD or autoinjector in healthy participants.

2022-12-16

2024-01-26

2024-01-26

Active (not recruiting)

Early phase I

140

Inclusion criteria: * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, clinical laboratory tests, vital sign measurements, and 12-lead electrocardiogram results. * Body weight greater than or equal to (\>=) 50 kilograms (kg) (110 pounds-mass/Ibs) and body mass index within the range 19 to 30 kg per meter square (inclusive). * Women who have the potential to become pregnant must use a form of highly-effective contraception. * Capable of giving signed informed consent. Exclusion Criteria: * History or presence of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, 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. * Participants with allergy/intolerance to a monoclonal antibody or biologic or participants with a previous history of clinically significant multiple or severe drug allergies/intolerance. * Current evidence or recent history of an infective illness. * A positive pre-study drug/alcohol screen or a history (or suspected history) of alcohol misuse or substance abuse * Clinically significant abnormalities. * Positive test for severe acute respiratory syndrome coronavirus (SARS-CoV-2) at screening. * Recent prior or concurrent clinical study experience.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a randomized, multicenter, open-label study in healthy adult participants.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 140, 'type': 'ESTIMATED'}}

2023-05-12