CompletedPhase 1

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

United States140 participantsStarted 2022-12-13

Plain-language summary

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

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial compared two different ways to inject depemokimab — a safety syringe device and an autoinjector — so how does knowing which delivery method works best actually affect my treatment options for asthma going forward?
2Since this was a Phase 1 study focused on how the drug moves through the body rather than whether it treats asthma effectively, what do we actually know so far about depemokimab's safety and real-world benefit for patients like me?
3The trial is now completed — do you know if the results showed that the autoinjector and the safety syringe delivered the drug in a comparable way, and does that matter for how this drug might eventually be prescribed?
4Given that this study was done in healthy adults rather than people with asthma, how much can its findings realistically tell us about how depemokimab would work in my situation?
5Are there other trials of depemokimab that are specifically studying its effectiveness in asthma patients, and would it be worth exploring those instead of or alongside what this PK study found?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Maximum Observed Plasma Concentration (Cmax) of Depemokimab

Timeframe: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose

Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0-inf]) of Depemokimab

Timeframe: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose

Trial details

NCT IDNCT05602025

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-10-23

Results submitted2026-04-08

View on ClinicalTrials.gov More Asthma trials

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Maximum Observed Plasma Concentration (Cmax) of Depemokimab

Timeframe: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose

Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0-inf]) of Depemokimab

Timeframe: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose