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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 1

Conditions

Asthma

Treatments

Biological: Depemokimab

Study type

Interventional

Funder types

Industry

Identifiers

NCT05602025

214099

Details and patient eligibility

About

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

Enrollment

140 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.