A Comparative Study to Investigate the Difference in Blood Levels of Two Different Formulations of GSK5784283
Recruiting
Phase 1Interventional Study
Asthma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 60
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
24 (estimated)
Sponsor
GlaxoSmithKline · Industry
Who this trial is looking for
This trial is looking for healthy adults to compare how two types of a medicine for asthma work in the body. Participants will receive study medicine and share how their bodies process it over time.
Are You a Good Fit for This Trial?
You may be able to join if
I am healthy as determined by medical evaluation.
I weigh at least 50 kg (110 lbs).
I have a body mass index (BMI) between 19 and 30.
I can provide signed informed consent.
You may not be able to join if
I have a history of allergy to biologic therapy.
I have significant medical conditions that affect my ability to participate.
I have abnormal findings in blood tests or physical exams that may put me at risk.
I received a live vaccine within the past month.
I have used biologic agents in the last 3 months.
I am currently a smoker or have a significant smoking history.
I regularly consume alcohol above specified limits.
My QTc interval is greater than 450 milliseconds.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
The purpose of this study is to compare how two different formulations of the study medicine (GSK5784283) move through the body over time (pharmacokinetic \[PK\] study) in healthy adults. The aim of the study is to see how the body processes GSK5784283 and determine if the study medicine is safe, how well it is tolerated by the body and if the study medicines being tested work in the body in the s…
The purpose of this study is to compare how two different formulations of the study medicine (GSK5784283) move through the body over time (pharmacokinetic \[PK\] study) in healthy adults. The aim of the study is to see how the body processes GSK5784283 and determine if the study medicine is safe, how well it is tolerated by the body and if the study medicines being tested work in the body in the same way.
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Eligibility Criteria
Inclusion Criteria:
* Participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG.
* Body weight greater than or equal (\>=) 50 kilogram (kg) (110 pounds \[lbs\]) and body mass index within the range 19 to 30 kilogram p…
Inclusion Criteria:
* Participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG.
* Body weight greater than or equal (\>=) 50 kilogram (kg) (110 pounds \[lbs\]) and body mass index within the range 19 to 30 kilogram per meter square (kg/m\^2) (inclusive).
* A female participant is eligible to participate if she is a participant of non-childbearing potential (PONCBP) as specified in the protocol.
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Exclusion Criteria:
* Hypersensitivity- Participants with allergy/intolerance to any biologic therapy or any of the known excipients used in products administered subcutaneously
* History or presence of any clinically significant medical condition 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.
* Any clinically relevant abnormal findings in physical examination, hematology, clinical chemistry, urinalysis, vital signs during screening period which in the opinion of the investigator, may put the subject at risk because of his/her participation in the study, or may influence the results of the study, or the subject's ability to participate in the study.
* Live vaccine(s) within 1 month prior to screening or plans to receive such vaccines during the clinical study.
* Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to study intervention administration.
* Current smokers (tobacco and/or marijuana) or former smokers with a smoking history \>10 pack-years and participants using vaping products, including electronic cigarettes.
* Regular alcohol consumption that exceeds the limits specified in the protocol
* Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the clinical study.
* The QTc is the QT interval corrected for heart rate according to Fridericia's formula (QTcF), machine-read or manually over-read \>450 millisecond (msec).
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