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A Study to Compare the Pharmacokinetics (PK) of Depemokimab When Delivered With a Safety Syringe Device (SSD) or an Autoinjector in Healthy Adult Participants

NCT05602025

CompletedPhase 1

Sponsor: GlaxoSmithKline

Conditions: Asthma

Interventions: Depemokimab

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 18 Years to 50 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (3)

Orlando, Florida, United States
Las Vegas, Nevada, United States
Austin, Texas, United States