A Study to Compare the Pharmacokinetics (PK) of Depemokimab When Delivered With a Safety Syringe Device (SSD) or an Autoinjector in Healthy Adult Participants
Completed · Phase 1
Conditions studied: Asthma
In brief
This study will compare the pharmacokinetics, safety, tolerability, and immunogenicity of Depemokimab administered via a SSD or autoinjector in healthy participants.
Key facts
- Study ID
- NCT05602025
- Run by
- GlaxoSmithKline
- People needed
- 140
- Starts
- 2022-12-13
- Expected to finish
- 2023-10-23
- Last updated by the study team
- 2026-06-16
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- GSK Investigational Site — Orlando, Florida, United States
- GSK Investigational Site — Las Vegas, Nevada, United States
- GSK Investigational Site — Austin, Texas, United States
Full record on ClinicalTrials.gov
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