Clinical trial NCT05602025: A Study to Compare the Pharmacokinetics (PK) of Depemokimab When Delivered With a Safety Syringe Device (SSD) or an Autoinjector in Healthy Adult Participants
Official title: An Open-Label, Randomized, Single-Dose, Multicenter, Parallel-Group Study to Compare the Pharmacokinetics of Subcutaneous Depemokimab When Delivered With a Safety Syringe Device or an Autoinjector in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Keywords: Autoinjector
Depemokimab
Healthy Participants
Safety Syringe Device
Pharmacokinetics
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: PPD Development, LP
First posted: 2022-11-01
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized, multicenter, open-label study in healthy adult participants.
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax) of depemokimab
timeFrame: Up to Week 26
measure: Area under the concentration-time curve from time zero extrapolated to infinity (AUC[0-inf]) of depemokimab
timeFrame: Up to Week 26
Secondary outcomes:
measure: Area under the concentration time curve from time zero to time of last observed quantifiable concentration (AUC[0-t]) of depemokimab
timeFrame: Up to week 26
measure: Time to maximum observed plasma concentration (Tmax) of depemokimab
timeFrame: Up to Week 26
measure: Apparent clearance following extravascular administration (CL/F) of depemokimab
timeFrame: Up to Week 26
measure: Apparent volume of distribution following extravascular administration (Vd/F) of depemokimab
timeFrame: Up to week 26
measure: Terminal elimination rate constant (lambda z) of depemokimab
timeFrame: Up to Week 26
measure: Terminal elimination half life (T1/2) of depemokimab
timeFrame: Up to Week 26
measure: Time of last measurable plasma concentrations (Tlast) of depemokimab
timeFrame: Up to week 26
measure: Percentage of AUC(0-inf) due to extrapolation from Tlast to infinity (%AUCex) of depemokimab
timeFrame: Up to Week 26
measure: Number of participants with presence of anti-drug antibody and neutralizing antibody to depemokimab
timeFrame: Pre-dose and Weeks 4, 8, 12, 26 post dose
Other outcomes:
Locations:
city: Orlando
country: United States
facility: GSK Investigational Site
state: Florida
city: Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: