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

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

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

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Biological: Depemokimab

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32806
      • GSK Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89113
      • GSK Investigational Site
  • Texas
    • Austin, Texas, United States, 78744
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants receiving depemokimab via a SSD	Biological: Depemokimab; Depemokimab will be administered via a SSD or autoinjector.
Experimental: Participants receiving depemokimab via an autoinjector	Biological: Depemokimab; Depemokimab will be administered via a SSD or autoinjector.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum observed plasma concentration (Cmax) of depemokimab	Up to Week 26
Area under the concentration-time curve from time zero extrapolated to infinity (AUC[0-inf]) of depemokimab	Up to Week 26

Secondary Outcome Measures

Outcome Measure	Time Frame
Area under the concentration time curve from time zero to time of last observed quantifiable concentration (AUC[0-t]) of depemokimab	Up to week 26
Time to maximum observed plasma concentration (Tmax) of depemokimab	Up to Week 26
Apparent clearance following extravascular administration (CL/F) of depemokimab	Up to Week 26
Apparent volume of distribution following extravascular administration (Vd/F) of depemokimab	Up to week 26
Terminal elimination rate constant (lambda z) of depemokimab	Up to Week 26
Terminal elimination half life (T1/2) of depemokimab	Up to Week 26
Time of last measurable plasma concentrations (Tlast) of depemokimab	Up to week 26
Percentage of AUC(0-inf) due to extrapolation from Tlast to infinity (%AUCex) of depemokimab	Up to Week 26
Number of participants with presence of anti-drug antibody and neutralizing antibody to depemokimab	Pre-dose and Weeks 4, 8, 12, 26 post dose

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Collaborators: PPD
• Investigators: Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2022
• Primary Completion (Actual): October 23, 2023
• Study Completion (Actual): October 23, 2023

Study Registration Dates

• First Submitted: October 27, 2022
• First Submitted That Met QC Criteria: October 27, 2022
• First Posted (Actual): November 1, 2022

Study Record Updates

• Last Update Posted (Actual): June 17, 2024
• Last Update Submitted That Met QC Criteria: June 14, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Healthy Participants; Autoinjector; Depemokimab; Safety Syringe Device
• Other Study ID Numbers: 214099

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
• IPD Sharing Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• IPD Sharing Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No